Label: INDIGO SOOTHING TRIPLE RECOVERY CREAM- colloidal oatmeal lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69417-100-03 - Packager: TATCHA 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 June 16, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Purpose
- Active Ingredients
- Uses
- Warnings
- Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
- Directions
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Inactive Ingredients
WATER, SQUALANE, GLYCERIN, PROPANEDIOL, CYCLOPENTASILOXANE,
DIISOSTEARYL MALATE, ORYZA SATIVA (RICE) BRAN WAX, XYLITOL,
BEHENYL ALCOHOL, POLYGONUM TINCTORIUM (JAPANESE INDIGO)
LEAF/STEM EXTRACT, INDIGOFERA TINCTORIA LEAF EXTRACT, AVENA
SATIVA (OAT) KERNEL EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF
EXTRACT, COCOS NUCIFERA (COCONUT) OIL, SOPHORA JAPONICA FLOWER
EXTRACT, PRUNUS LANNESIANA FLOWER EXTRACT, ORYZA SATIVA (RICE)
GERM OIL, INOSITOL (RICE EXTRACT), SERICIN (SILK EXTRACT),
TETRASODIUM TETRACARBOXYMETHYL NARINGENINCHALCONE,
CHONDRUS CRISPUS (RED ALGAE) EXTRACT, AMORPHOPHALLUS KONJAC
ROOT POWDER, SODIUM HYALURONATE, DEXTRIN, SORBITAN
TRISTEARATE, TRIHYDROXYSTEARIN, DIMETHICONE, DIMETHICONE/VINYL
DIMETHICONE CROSSPOLYMER, BEHENETH-20, BIS-DIGLYCERYL
POLYACYLADIPATE-2, ETHYLHEXYLGLYCERIN, SODIUM
DILAURAMIDOGLUTAMIDE LYSINE, DISODIUM EDTA, ETHYLHEXYL
PALMITATE, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/
DIMETHYLACRYLAMIDE CROSSPOLYMER, TITANIUM DIOXIDE, CALCIUM
CARBONATE, TIN OXIDE, PHENOXYETHANOL, MICA - Other Information
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
INDIGO SOOTHING TRIPLE RECOVERY CREAM
colloidal oatmeal lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69417-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 3 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SQUALANE (UNII: GW89575KF9) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) XYLITOL (UNII: VCQ006KQ1E) BEHENETH-20 (UNII: BJ4GP2IFLN) SODIUM ACRYLATE (UNII: 7C98FKB43H) SORBITAN TRISTEARATE (UNII: 6LUM696811) DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) INOSITOL (UNII: 4L6452S749) AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) INDIGOFERA TINCTORIA LEAF (UNII: 2K7DF8HZDM) SERICIN 1 (UNII: N6466G03F7) ETHYLHEXYL PALMITATE (UNII: 2865993309) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) CHONDRUS CRISPUS (UNII: OQS23HUA1X) AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG) PRUNUS APETALA WHOLE (UNII: 70PO4VL8CO) SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L) DEXTRAN 1 (UNII: I8LHQ0D645) CALCIUM CARBONATE (UNII: H0G9379FGK) POLYGONUM ARENASTRUM WHOLE (UNII: M7IQ4O4186) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69417-100-03 10 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 part347 06/16/2015 Labeler - TATCHA INC. (006811461)
