Purpose

Skin Protectant

Active Ingredients

Colloidal Oatmeal 3.00%

Uses

Temporarily protects and helps releive minor skin irritation and itching due to eczema rashes

Warnings

When using this product do not get into eyes

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed.

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

Store at 20-25C (68-77)F

Principal Display Panel

69417-100-17

INDIGO SOOTHING TRIPLE RECOVERY CREAM
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69417-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	3 g in 50 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69417-100-17	50 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/30/2015

Labeler - TATCHA INC. (006811461)

DRUG FACTS