Label: DERMACLEAR MASK- salicylic acid cream
- NDC Code(s): 62742-4074-1, 62742-4074-2
- Packager: Allure Labs 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.
Drug Label Information
Updated November 30, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
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WHEN USING
When using this product:
- Avoid contact with the eyes, lips and mouth.
- Using other topical acne medications at the same time or immediately following 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.
- If sensitive to the sun or when increased sun exposure is expected use a sunscreen.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
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DOSAGE & ADMINISTRATION
Directions:
- Apply thin layer in affected areas after cleansing using finger tips.
- Massage gently in circular movements for 1-2 minutes and allow the product to remain on skin for 5-10 minutes, depending on the skin tolerance and/or sensitivity.
- Rinse well and follow suggested post-mask home care regimen.
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INACTIVE INGREDIENT
Inavtive Ingredients:
Water (Aqua), Kaolin, Magnesium Aluminum Silicate, Glycerin, Butylene Glycol, Sodium Hyaluronate, Sodium Polystyrene Sulfonate, Xanthan Gum, Allantoin, Salix Alba (Willow) Bark Extract, Citrus Aurantium Dulcis (Orange) Callus Culture Extract , Crithmum Maritimum Callus Culture Filtrate, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, PEG-60 Almond Glycerides, Carbomer, Nordihydroguaiaretic Acid, Oleanolic Acid, Niacinamide, Caprylic/Capric Triglyceride, Ethyl Linoleate, Hexylresorcinol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Maltodextrin, Carrageenan , Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Citric Acid,
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMACLEAR MASK
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4074 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) KAOLIN (UNII: 24H4NWX5CO) GLYCERIN (UNII: PDC6A3C0OX) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) ORANGE (UNII: 5EVU04N5QU) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) MALTODEXTRIN (UNII: 7CVR7L4A2D) ALOE VERA LEAF (UNII: ZY81Z83H0X) NIACINAMIDE (UNII: 25X51I8RD4) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) HEXYLRESORCINOL (UNII: R9QTB5E82N) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SYRINGA VULGARIS WHOLE (UNII: U49SHU1VCI) MASOPROCOL (UNII: 7BO8G1BYQU) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SALIX ALBA BARK (UNII: 205MXS71H7) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARRAGEENAN (UNII: 5C69YCD2YJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4074-2 1 in 1 CARTON 05/04/2015 1 NDC:62742-4074-1 56.7 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/04/2015 Labeler - Allure Labs Inc, (926831603) Registrant - Allure Labs Inc, (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4074)
