Label: CLEANSER ACNE CLEARING TREATMENT- benzoyl peroxide liquid
- 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 March 20, 2013
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- ACTIVE INGREDIENT
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
Warnings: For external use only. When using this product skin irritation and dryness may occur.
Do not use
- if you have sensitive skin and/or are sensitive to Sulphur
- on broken skin
- on skin that ha no breakouts
- 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 SPL 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
- KEEP OUT OF REACH OF CHILDREN
INDICATIONS & USAGE
- cleanse skin with ACNE CLEARING CLEANSER a benzoyl peroxide acne medication cleansing gel.
- moisten fresh cotton ball with ACNE CLEARING TONIC a salicylic acid serum medication for oil control.
- apply ACNE CLEARING TREATMENT 101 a sulphur and natural anti-inflammatory lotion medication to acne breakout areas.
- start with one application daily then gradually increase to 2 or 3.
- if going outside after cleansing apply sun screen, Acne Clearing Moisture with SPF 45
- if excessive irritation or sensitivity develops stop use of both products and contact a physician.
Ingredients: 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
INGREDIENTS AND APPEARANCE
CLEANSER ACNE CLEARING TREATMENT
benzoyl peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51439-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE .006 mg in .024 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9) ETHYLENE GLYCOL (UNII: FC72KVT52F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) TROLAMINE (UNII: 9O3K93S3TK) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) VITAMIN A (UNII: 81G40H8B0T) ASCORBIC ACID (UNII: PQ6CK8PD0R) WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) POMEGRANATE (UNII: 56687D1Z4D) GREEN TEA LEAF (UNII: W2ZU1RY8B0) EDETIC ACID (UNII: 9G34HU7RV0) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51439-005-01 .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(51439-005)