Label: CHARCOAL ACNE SCRUB HELP CLEAR ACNE BLEMISHES- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58503-115-01 - Packager: China Ningbo Shangge Cosmetic Technology Corp.
- 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 December 16, 2018
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- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Directions
- Wet face
- Squeeze product into hands
- Massage over entire face and rinse thoroughly
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 3 times daily if needed or as directly by a doctor
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, GLYCERIN, SORBITOL, SYNTHETIC WAX, MICROCRYSTALLINE WAX, CHARCOAL POWDER, XANTHAN GUM, SODIUM BENZOATE, FRAGRANCE, POLYQUATERNIUM-39, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, DISODIUM EDTA, MENTHOL, SODIUM HYDROXIDE
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WARNINGS
Warnings
For external use only
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, oinly use one topical acne medication at a time.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHARCOAL ACNE SCRUB HELP CLEAR ACNE BLEMISHES
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE VERA LEAF (UNII: ZY81Z83H0X) SORBITOL (UNII: 506T60A25R) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) XANTHAN GUM (UNII: TTV12P4NEE) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) SODIUM BENZOATE (UNII: OJ245FE5EU) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) MENTHOL (UNII: L7T10EIP3A) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58503-115-01 91 g in 1 BOTTLE; Type 0: Not a Combination Product 12/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/16/2018 Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(58503-115)
