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Clinac (Benzoyl Peroxide Topical) - Warnings and Precautions

 
 



WARNINGS

FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, eyelids, lips and mucous membranes. If inadvertent contact occurs, rinse area thoroughly with water. Contact with colored material, including fabric and hair, may result in discoloration. When using Clinac® BPO 7, avoid unnecessary sun exposure and use a sunscreen. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

PRECAUTIONS

INFORMATION FOR PATIENTS

  • Avoid contact with eyes, eyelids, lips and mucous membranes.
  • May discolor hair and fabrics.
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Use of oil-free make-up recommended.
  • If severe irritation develops, discontinue use and consult your physician.

CARCINOGENESIS, MUTAGENESIS AND IMPAIRMENT OF FERTILITY

Studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is not known. Benzoyl peroxide has not been found to be mutagenic (Ames test) and there are no published data indicating that it impairs fertility.

PREGNANCY: CATEGORY C

Animal reproductive 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 used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.

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 children below the age of 12 have not been established.

Page last updated: 2006-10-02

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