Label: FOAMIMG ACNE FACE WASH- benzoyl peroxide 10% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-666-05 - 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 24, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Keep out of reach of children. If swallowed, get medicalhelp or contact a Poison Control Center right away.
- 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 - DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients
Water, Sodium Cocoyl Isethionate, Cetearyl Alcohol, Cocamidopropyl Betaine, Potassium Lauryl Phosphate, Glycerin, Sodium
Hydroxide, Glycolic Acid, Mineral Oil, Lactic Acid, Titanium
Dioxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Sodium PCA, Sodium Lauryl Sulfoacetate, Disodium Laureth
Sulfosuccinate, Phenoxyethanol, Ethylhexylglycerin. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FOAMIMG ACNE FACE WASH
benzoyl peroxide 10% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-666 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide 10 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) 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:69842-666-05 187 g in 1 TUBE; Type 0: Not a Combination Product 03/29/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 03/29/2018 Labeler - CVS (062312574) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(69842-666) , label(69842-666)