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Benzagel

Warnings & Precautions
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WARNINGS

If itching, redness, burning, swelling or undue dryness occurs, discontinue use.

PRECAUTIONS

For external use only. Not for ophthalmic use. Keep away from eyes and mucosae. Very fair individuals should begin with a single application at bedtime allowing overnight medication. May bleach colored fabrics. Keep this and all medications out of the reach of children.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Brand Name: Benzagel
Generic Name: Benzoyl Peroxide Gel

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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