Label: ORGANIC TEA TREE TREATMENT GEL- salicylic acid 2% gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71643-1019-1 - Packager: HERRCO COSMETICS LIMITED
- 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 12, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ORGANIC TEA TREE TREATMENT GEL
salicylic acid 2% gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71643-1019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength BILBERRY (UNII: 9P2U39H18W) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) COCO-CAPRYLATE (UNII: 4828G836N6) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SUGARCANE (UNII: 81H2R5AOH3) ORANGE (UNII: 5EVU04N5QU) ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC) LEMON OIL (UNII: I9GRO824LL) ROSEMARY OIL (UNII: 8LGU7VM393) LIME OIL (UNII: UZH29XGA8G) SALIX ALBA BARK (UNII: 205MXS71H7) TEA TREE OIL (UNII: VIF565UC2G) SPEARMINT OIL (UNII: C3M81465G5) CUCUMBER (UNII: YY7C30VXJT) CHAMOMILE (UNII: FGL3685T2X) CITRUS PARADISI SEED (UNII: 12F08874Y7) ECHINACEA PURPUREA (UNII: QI7G114Y98) DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHYTATE SODIUM (UNII: 88496G1ERL) SODIUM HYDROXIDE (UNII: 55X04QC32I) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) GRAPEFRUIT PEEL (UNII: 3582N05Q44) LEMON (UNII: 24RS0A988O) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71643-1019-1 10 mL in 1 BOX; Type 0: Not a Combination Product 09/26/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/26/2019 Labeler - HERRCO COSMETICS LIMITED (211536385) Registrant - HERRCO COSMETICS LIMITED (211536385)
