Label: BLEMISH- benzoyl peroxide gel
- NDC Code(s): 63550-193-23
- Packager: Kamins Dermatologics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated December 30, 2019
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
INDICATIONS & USAGE
A unique oil-free, color-free benzoyl peroxide gel that helps to gently clear blemishes, blackheads and spots. Also contains our moisturizing Bio-Maple compound, which helps prevent skin from becoming excessively dry.
■ Helps treat acne.
■ Dries up acne pimples.
■ Helps prevent new acne pimples.
For external use only.
Do not use on
- broken skin.
- large areas of the body.
When using this product,
- Apply to affected areas only
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with eyes/eye area, lips, mouth and nostrils. If contact occurs, rinse thoroughly with water.
- This product may bleach hair or dyed fabrics.
- Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor.
Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.
If swallowed, seek medical assistance or contact a Poison Control Center immediately.
DOSAGE & ADMINISTRATION
- Clean the skin thoroughly befor applying.
- Cover the entire affected area with a thin layer 1 to 3 times daily.
- because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- If going outside, use a sunscreen. Allow medicated acne gel to dry, then follow directions on the sunscreen labeling.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-193 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ACER SACCHARUM SAP (UNII: 75UOH57984) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63550-193-23 30 mL in 1 BOX; Type 0: Not a Combination Product 10/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/01/2010 Labeler - Kamins Dermatologics Inc. (254050784) Registrant - Kamins Dermatologics Inc. (254050784) Establishment Name Address ID/FEI Business Operations Odan Laboratories Ltd 208585604 manufacture(63550-193) , pack(63550-193)