pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration. pHisoHex contains a colloidal dispersion of hexachlorophene 3% (w/w) in a stable emulsion consisting of entsufon sodium, petrolatum, lanolin cholesterols, methylcellulose, polyethylene glycol, polyethylene glycol monostearate, lauryl myristyl diethanolamide, sodium benzoate, and water. pH is adjusted with hydrochloric acid. Entsufon sodium is a synthetic detergent.

Chemically, hexachlorophene is Phenol, 2,2'-methylenebis[3,4,6-trichloro-; and has the following structural formula:

Last updated on RxList: 5/21/2008

pHisoHex is indicated for use as a surgical scrub and a bacteriostatic skin cleanser. It may also be used to control an outbreak of gram-positive infection where other infection control procedures have been unsuccessful. Use only as necessary for infection control.

Surgical Hand Scrub

1. Wet hands and forearms with water. Apply approximately 5 mL of pHisoHex over the hands and rub into a copious lather by adding small amounts of water. Spread suds over hands and forearms and scrub well with a wet brush for 3 minutes. Pay particular attention to the nails and interdigital spaces. A separate nail cleaner may be used. Rinse thoroughly under running water.
2. Apply 5 mL of pHisoHex to hands again and scrub as above for another 3 minutes. Rinse thoroughly with running water and dry.
3. For repeat surgical scrubs during the day, scrub thoroughly with the same amount of pHisoHex for 3 minutes only. Rinse thoroughly with water and dry.

Bacteriostatic Cleansing

Wet hands with water. Dispense approximately 5 mL of pHisoHex into the palm, work up a lather with water and apply to area to be cleansed.

Rinse thoroughly after each washing.

INFANT CARE: pHisoHex should not be used routinely for bathing infants. See WARNINGS.

PREMATURE INFANTS: See WARNINGS.

Use of baby skin products containing alcohol may decrease the antibacterial action of pHisoHex.

5 oz plastic squeeze bottle
(NDC 0024-1535-02).

1 pint plastic squeeze bottle
(NDC 0024-1535-06).

1 gallon plastic bottle
(NDC 0024-1535-08).

Prolonged direct exposure of pHisoHex to strong light may cause brownish surface discoloration but does not affect its antibacterial or detergent properties. Shaking will disperse the color. If pHisoHex is spilled or splashed on porous surfaces, rinse off to avoid discoloration.

Directions For Cleaning Dispensers: Before initial installation and use, run an antiseptic, such as an aqueous solution of benzalkonium chloride, NF. 1:500 to 1:750, or alcohol, through the working parts; rinse with sterile water. At weekly intervals thereafter, remove dispenser and pour off remainder of pHisoHex emulsion. Rinse empty dispenser with water. Run water through the working parts by operating the dispenser. Sanitize as described above. Rinse thoroughly with sterile water.

Animal Toxicity

The oral LD₅₀ of hexachlorophene in male rats is 66 mg/kg bw, in females 56 mg/kg bw, and in weanling rats 120 mg/kg bw.

In suckling rats (10-days old), it is 9 mg/kg bw.

Store at room temperature up to 25° C (77° F)

Manufactured for: Sanofi-Synthelabo Inc. New York, NY 10016. by: Bayer Corporation Myerstown, PA 17067. Revised April 2003. FDA Rev date: 5/27/2003

Last updated on RxList: 5/21/2008

Adverse reactions to pHisoHex may include dermatitis and photosensitivity. Sensitivity to hexachlorophene is rare; however, persons who have developed photoallergy to similar compounds also may become sensitive to hexachlorophene.

In persons with highly sensitive skin the use of pHisoHex may at times produce a reaction characterized by redness and/or mild scaling or dryness, especially when it is combined with such mechanical factors as excessive rubbing or exposure to heat or cold.

No information available.

Last updated on RxList: 5/21/2008

RINSE THOROUGHLY AFTER EACH USE. Patients should be closely monitored and use should be immediately discontinued at the first sign of any of the symptoms described below.

Rapid absorption of hexachlorophene may occur with resultant toxic blood levels when preparations containing hexachlorophene are applied to skin lesions such as ichthyosis congenita, the dermatitis of Letterer-Siwe's syndrome, or other generalized dermatological conditions. Application to burns has also produced neurotoxicity and death.

pHisoHex SHOULD BE DISCONTINUED PROMPTLY IF SIGNS OR SYMPTOMS OF CEREBRAL IRRITABILITY OCCUR.

Infants, especially premature infants or those with dermatoses, are particularly susceptible to hexachlorophene absorption. Systemic toxicity may be manifested by signs of stimulation (irritation) of the central nervous system, sometimes with convulsions.

Infants have developed dermatitis, irritability, generalized clonic muscular contractions and decerebrate rigidity following application of a 6 percent hexachlorophene powder. Examination of brainstems of those infants revealed vacuolization like that which can be produced in newborn experimental animals following repeated topical application of 3 percent hexachlorophene. Moreover, a study of histologic sections of premature infants who died of unrelated causes has shown a positive correlation between hexachlorophene baths and lesions in white matter of brains.

General

Avoid accidental contact of pHisoHex with the eyes.

If contact occurs, promptly rinse thoroughly with water. To assist in the detection of ocular irritation, applications to the head and periorbital skin areas should be performed only in responsive patients with unanesthetized eyes.

RINSE THOROUGHLY AFTER USE, especially from sensitive areas such as the scrotum and perineum.

pHisoHex is intended for external use only. If swallowed, pHisoHex is harmful, especially to infants and children.

pHisoHex should not be poured into measuring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies in animals

Hexachlorophene was tested in one experiment in rats by oral administration; it had no carcinogenic effect.

Hexachlorophene was not mutagenic in Salmonella typhimurium and was negative in a dominant lethal assay in male mice. Cytogenetic tests with cultured human lymphocytes were also negative.

Human data

No case reports or epidemiological studies were available.

Impairment of fertility

Topical exposure of neonatal rats to 3% hexachlorophene solution caused reduced fertility in 7-month-old males, due to inability to ejaculate.

Embryotoxicity and Teratogenicity

Placental transfer of hexachlorophene has been demonstrated in rats.

Hexachlorophene is embryotoxic and produces some teratogenic effects.

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Hexachlorophene should be used during pregnancy only if the potential benefit justifies potential risk to the fetus.

Hexachlorophene has been shown to be teratogenic and embryotoxic in rats when given by mouth or instilled into the vagina in large doses.

Administration of 500 mg/kg diet or 20 to 30 mg/kg bw/day by gavage to rats caused some malformations (angulated ribs, cleft palate, micro- and anophthalmia) and reduction in litter size.

Placental transfer and excretion in milk of hexachlorophene has been demonstrated in rats.

In another study, doses of up to 50 mg/kg diet failed to produce any effects in 3 generations of rats. Hexachlorophene did not interfere with reproduction in hamsters.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hexachlorophene, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

Geriatric Use

Clinical studies of pHisoHex did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, use in elderly patients should be cautious, reflecting the greater frequency of dermatological disease, peripheral circulatory disease, and decreased propensity for wound healing in this group. In addition, use in elderly patients should take into account any decreased hepatic, renal, or cardiac function, as well as any concomitant disease or other drug therapy.

Pediatric Use

pHisoHex should not be used routinely for bathing infants. See WARNINGS. For premature infants: see WARNINGS.

Last updated on RxList: 5/21/2008

The accidental ingestion of pHisoHex in amounts from 1 oz to 4 oz has caused anorexia, vomiting, abdominal cramps, diarrhea, dehydration, convulsions, hypotension, and shock, and in several reported instances, fatalities.

If patients are seen early, the stomach should be evacuated by emesis or gastric lavage. Olive oil or vegetable oil (60 mL or 2 fl oz) may then be given to delay absorption of hexachlorophene, followed by a saline cathartic to hasten removal. Treatment is symptomatic and supportive; intravenous fluids (5 percent dextrose in physiologic saline solution) may be given for dehydration. Any other electrolyte derangement should be corrected. If marked hypotension occurs, vasopressor therapy is indicated. Use of opiates may be considered if gastrointestinal symptoms (cramping, diarrhea) are severe. Scheduled medical or surgical procedures should be postponed until the patient's condition has been evaluated and stabilized.

pHisoHex should not be used on burned or denuded skin.

It should not be used as an occlusive dressing, wet pack, or lotion.

It should not be used routinely for prophylactic total body bathing.

It should not be used as a vaginal pack or tampon, or on any mucous membranes.

pHisoHex should not be used on persons with sensitivity to any of its components. It should not be used on persons who have demonstrated primary light sensitivity to halogenated phenol derivatives because of the possibility of cross-sensitivity to hexachlorophene.

Last updated on RxList: 5/21/2008

pHisoHex is a bacteriostatic cleansing agent. It cleanses the skin thoroughly and has bacteriostatic action against staphylococci and other gram-positive bacteria. Cumulative antibacterial action develops with repeated use. Cleansing with alcohol or soaps containing alcohol removes the antibacterial residue.

Detectable blood levels of hexachlorophene following absorption through intact skin have been found in subjects who regularly scrubbed with hexachlorophene emulsion 3%. (See WARNINGS for additional information.)

pHisoHex has the same slight acidity as normal skin (pH value 5.0 to 6.0).

Last updated on RxList: 5/21/2008

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 5/21/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

HEXACHLOROPHENE - CLEANSER

(hex-uh-KLOR-oh-feen)

COMMON BRAND NAME(S): Phisohex, Septisol

USES: This medication is a skin cleanser that kills certain types of bacteria (e.g., staph). It is used to help prevent passing germs to others.

HOW TO USE: Wet hands with water and apply a small amount (about 1 teaspoon or 5 milliliters) on the palm of the hand. Work into a lather with water and wash the affected area with the lather as directed by your doctor. Immediately rinse the area well after washing, especially if washing genital or anal areas.

This medication should be used on normal skin only. Do not use on red/broken/cut/irritated/scraped/burned skin. Be careful to avoid your eyes. If contact occurs, flush the eyes well with cool water. Do not use on mucous membranes (inside nose/mouth/vagina/anus/rectum). This cleanser should not be used regularly to wash the entire body, especially in infants and children.

Do not leave the medication on the skin. Do not cover the area with plastic or waterproof bandages.

For best results, use as directed. Do not use large amounts, use more often, or keep using it for a longer time than directed. Overuse of this product can allow the medication to be absorbed into the body, possibly causing serious side effects.

SIDE EFFECTS: Skin reactions including redness, dryness, and scaling may occur. Long/hard rubbing or exposure to heat or cold may worsen these effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (e.g., agitation, extreme sleepiness), skin infection (e.g., warm/red/itchy skin, swelling, pus), stiff muscles, muscle spasms, difficulty moving/walking, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using hexachlorophene, tell your doctor or pharmacist if you are allergic to it; or to other halogenated phenols (e.g., chlorocresol, trichlorophenol); or to inactive ingredients such as lanolin; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin infections/problems (e.g., eczema, psoriasis, dryness, scaling).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in infants and children because they may be more sensitive to the effects of the drug, especially seizures. It should not be used regularly for bathing infants.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: skin products that contain alcohol.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose/swallowing may include: loss of appetite, vomiting, stomach cramps, diarrhea, and seizures.

NOTES: Do not share this medication with others.

This product may stain porous surfaces and discolor/harm metal surfaces (e.g., stainless steel).

MISSED DOSE: If you miss an application, use it as soon as you remember. Do not use more of this product to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light. Keep all medicines away from children and pets. Hexachlorophene is very harmful if swallowed, especially to infants and children. Store in original container to prevent accidental swallowing. Do not pour into other containers (e.g., measuring cups, medicine bottles) that may be mistaken for food or other medication.

Hexachlorophene may turn brown when exposed to light for a long time. This does not affect how well it will work. Shake the container well to improve the color.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.