"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
pHisoHex (hexachlorophene) 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.
DOSAGE AND ADMINISTRATION
Surgical Hand Scrub
- Wet hands and forearms with water. Apply approximately 5 mL of pHisoHex (hexachlorophene) 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.
- Apply 5 mL of pHisoHex (hexachlorophene) to hands again and scrub as above for another 3 minutes. Rinse thoroughly with running water and dry.
- For repeat surgical scrubs during the day, scrub thoroughly with the same amount of pHisoHex (hexachlorophene) for 3 minutes only. Rinse thoroughly with water and dry.
Wet hands with water. Dispense approximately 5 mL of pHisoHex (hexachlorophene) into the palm, work up a lather with water and apply to area to be cleansed.
Rinse thoroughly after each washing.
INFANT CARE: pHisoHex (hexachlorophene) 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 (hexachlorophene) .
5 oz plastic squeeze bottle
1 pint plastic squeeze bottle
1 gallon plastic bottle
Prolonged direct exposure of pHisoHex (hexachlorophene) to strong light may cause brownish surface discoloration but does not affect its antibacterial or detergent properties. Shaking will disperse the color. If pHisoHex (hexachlorophene) is spilled or splashed on porous surfaces, rinse off to avoid discoloration.
pHisoHex (hexachlorophene) should not be dispensed from, or stored in, containers with ordinary metal parts. A special type of stainless steel must be used or undesirable discoloration of the product or oxidation of metal may occur.
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 (hexachlorophene) 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.
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 reviewed on RxList: 5/21/2008
This monograph has been modified to include the generic and brand name in many instances.
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