Label: CREAMY ACNE FACE WASH- benzoyl peroxide 4% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-444-05 - Packager: CVS
- 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 April 23, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
Do not use if you have very sensitive skin or if you
are sensitive to benzoyl peroxide.
When using this product • skin irritation and
dryness are 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. • rinse right away with water if it gets in eyes
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips, and mouth • avoid
contact with hair and dyed fabrics, which may be
bleached by this product • skin irritation may occur,
characterized by redness, burning, itching, peeling, or
possibly swelling. Irritation may be reduced by using
the product less frequently or in a lower concentration.
Stop use and consult a doctor if • irritation becomes severe. - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients
Water, Sodium Cocoyl Isethionate, Cetearyl Alcohol,
Cocamidopropyl Betaine, Potassium Lauryl Phosphate,
Glycerin, Disodium Laureth Sulfosuccinate, Sodium
Hydroxide, Glycolic Acid, Mineral Oil, Lactic Acid, Titanium
Dioxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Sodium PCA, Dimethyl Isosorbide, Sodium Lauryl
Sulfoacetate, Phenoxyethanol, Ethylhexylglycerin. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CREAMY ACNE FACE WASH
benzoyl peroxide 4% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-444 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide 4 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Dimethyl Isosorbide (UNII: SA6A6V432S) Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E) Ethylhexylglycerin (UNII: 147D247K3P) Glycerin (UNII: PDC6A3C0OX) Glycolic Acid (UNII: 0WT12SX38S) Lactic Acid (UNII: 33X04XA5AT) Mineral Oil (UNII: T5L8T28FGP) Phenoxyethanol (UNII: HIE492ZZ3T) Potassium Lauryl Phosphate (UNII: C4QT53N4MK) Sodium Cocoyl Isethionate (UNII: 518XTE8493) Sodium Hydroxide (UNII: 55X04QC32I) Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) Titanium Dioxide (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-444-05 204 g in 1 TUBE; Type 0: Not a Combination Product 06/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/20/2018 Labeler - CVS (062312574) Registrant - Product Quest Mdf (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mdf 927768135 manufacture(69842-444) , label(69842-444)