Label: MARY KAY ACNE TREATMENT ACNE MEDICATION- benzoyl peroxide gel
- NDC Code(s): 51531-0813-1
- Packager: Mary Kay 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 January 29, 2013
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- Active ingredient:
Benzoyl Peroxide 5%
- treats acne
- dries up acne pimples
- helps prevent new acne pimples
For external use only.
Do not use this product if
- you have very sensitive skin
- you are sensitive to benzoyl peroxide
- on large areas of the body
When using this product
- avoid unnecessary sun exposure and use sunscreen
- avoid eyes, lips and mouth
- this product may bleach hair or dyed fabrics
- this product may cause irritation
- using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- clean the skin thoroughly before applying.
- cover the entire affected area with a thin layer one to three times daily.
- because too much drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily, if needed or as directed by a doctor.
- if bothersome dryness or peeling occurs, reduce application to once a day or oevery other day.
- if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.
- Other information
- store at 59F to 86F
- expiration date on tube crimp
- Inactive ingredients
aesculus hippocastanum (horse chestnut) seed extract, butylene glycol, carbomer, cucumis sativus (cucumber) fruit extract, diethylhexyl sodium sulfosuccinate, disodium EDTA, echinacea purpurea extract, glycerin, poloxamer 182, propylene glycol, silica, sodium hydroxide, water.Close
- Principal Display Panel - 28 g carton
acne treatment gel
5% benzoyl peroxide
1 OZ. NET WT./28 g
- INGREDIENTS AND APPEARANCE
MARY KAY ACNE TREATMENT ACNE MEDICATION
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-0813 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 5 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Poloxamer 182 (UNII: JX0HIX6OAG) Silicon Dioxide (UNII: ETJ7Z6XBU4) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Sodium Hydroxide (UNII: 55X04QC32I) Docusate Sodium (UNII: F05Q2T2JA0) Edetate Disodium (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) Butylene Glycol (UNII: 3XUS85K0RA) Echinacea Purpurea (UNII: QI7G114Y98) Cucumber (UNII: YY7C30VXJT) Horse Chestnut (UNII: 3C18L6RJAZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-0813-1 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/19/1988 Labeler - Mary Kay Inc. (103978839) Establishment Name Address ID/FEI Business Operations Kolmar Laboratories Inc. 001535103 manufacture(51531-0813)