Label: ACNE CLEARNING TREATMENT FACE- sulfur, benzoyl peroxide, salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51439-007-01, 51439-007-02 - Packager: CarePluss Pharma S.A. de C.V.
- 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.
Drug Label Information
Updated March 20, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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PURPOSE
Uses:For the management of acne
- helps clear up acne blemishes, black heads, helps prevent the development of new acne pimples
- penetrates pores to reduce the number of acne pimples, white heads and black heads
- help keep skin clear of new acne pimples, white heads and black heads
- helps prevent new acne pimples, white heads and black heads from forming
- help prevent the development of new pimples, white heads and black heads
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WARNINGS
Warnings: For external use only.
Do not use
- if you have sensitive skin and/or are sensitive to [active ingredient]
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
- avoid unnecessary sun exposure and use sun screen, Acne Clearing Moisture with SPF 45
- skin irritation may occur, characterized by redness, burning, itching, peeling, and possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
irritation becomes severe - if you have sensitive skin and/or are sensitive to [active ingredient]
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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INACTIVE INGREDIENT
Ingredients: Purified Water, Ethyl Alcohol, Hamammelis Extract, Chamomile Extract, Salicyl Alcohol, Ethhylene Glycol, Propylene Glycol, Dodecyl Benzene Sulfonate, EDTA, Methylparaben, Propylparaben. Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben.Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE CLEARNING TREATMENT FACE
sulfur, benzoyl peroxide, salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51439-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR .012 mg in .024 mg BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE .006 mg in .024 mg SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID .0048 mg in .024 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CATALINA (UNII: T3JI0587Q7) ARNICA MONTANA (UNII: O80TY208ZW) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) CETEARETH-12 (UNII: 7V4MR24V5P) BROMELAINS (UNII: U182GP2CF3) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) MINERAL OIL (UNII: T5L8T28FGP) ETHYLENE GLYCOL (UNII: FC72KVT52F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) TROLAMINE (UNII: 9O3K93S3TK) ASCORBIC ACID (UNII: PQ6CK8PD0R) DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9) PEPPERMINT OIL (UNII: AV092KU4JH) PIPERINE (UNII: U71XL721QK) MINT (UNII: FV98Z8GITP) EDETIC ACID (UNII: 9G34HU7RV0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) VITAMIN A (UNII: 81G40H8B0T) POMEGRANATE (UNII: 56687D1Z4D) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51439-007-02 3 in 1 BOX 1 NDC:51439-007-01 .024 mg in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/06/2012 Labeler - CarePluss Pharma S.A. de C.V. (815061551) Registrant - CarePluss Pharma S.A. de C.V. (815061551) Establishment Name Address ID/FEI Business Operations CarePluss Pharma S.A. de C.V. 815061551 manufacture(51439-007)
