Label: OIL-FREE FOAMING ACNE WASH TEA TREE OIL- salicylic acid gel
- NDC Code(s): 57337-032-01, 57337-032-02
- Packager: Rejoice International
- Category: HUMAN OTC DRUG LABEL
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 May 19, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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Inactive ingredients
water, sodium c14-16 olefin sulfonate, cocamidopropyl betaine, acrylates copolymer, sodium chloride, microcrystalline wax, DMDM hydantoin, fragrance, disodium EDTA, sodium lauryl sulfate, sodium hydroxide, propylene glycol, melaleuca altemifolia (tea tree) leaf oil, fd&c blue no.1, fd&c yellow no.5.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OIL-FREE FOAMING ACNE WASH TEA TREE OIL
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 3 g in 150 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) SODIUM CHLORIDE (UNII: 451W47IQ8X) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) DMDM HYDANTOIN (UNII: BYR0546TOW) WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) SODIUM LAURYL SULFATE (UNII: 368GB5141J) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57337-032-01 50 g in 1 BOTTLE; Type 0: Not a Combination Product 11/20/2013 05/19/2023 2 NDC:57337-032-02 150 g in 1 BOTTLE; Type 0: Not a Combination Product 11/20/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/20/2013 Labeler - Rejoice International (078741245) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(57337-032)