THE INDIGO CREAM- colloidal oatmeal 2% cream

The Indigo Cream by

Drug Labeling and Warnings

The Indigo Cream by is a Otc medication manufactured, distributed, or labeled by TATCHA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active Ingredients

Colloidal Oatmeal 2%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to

• rashes
• eczema 

WARNINGS

Warnings

For external use only.

When using this product

• do not get into eyes

STOP USE

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Apply as needed.

INACTIVE INGREDIENT

Inactive ingredients

WATER/AQUA, SQUALANE, DIMETHICONE, PROPANEDIOL, GLYCERIN, DIISOSTEARYL MALATE, ORYZA SATIVA (RICE) BRAN WAX, BEHENYL ALCOHOL, SACCHAROMYCES/CAMELLIA SINENSIS LEAF/CLADOSIPHON OKAMURANUS/RICE FERMENT FILTRATE*, INDIGOFERA TINCTORIA LEAF EXTRACT, POLYGONUM TINCTORIUM LEAF/STEM EXTRACT, AVENA SATIVA (OAT) KERNEL EXTRACT, SOPHORA JAPONICA FLOWER EXTRACT, ORYZA SATIVA (RICE) GERM OIL, COCOS NUCIFERA (COCONUT) OIL, INOSITOL, SERICIN, TETRASODIUM TETRACARBOXYMETHYL NARINGENINCHALCONE, AMORPHOPHALLUS KONJAC ROOT POWDER, SODIUM HYALURONATE, SORBITAN TRISTEARATE, TRIHYDROXYSTEARIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BEHENETH-20, BIS-DIGLYCERYL POLYACYLADIPATE-2, ETHYLHEXYLGLYCERIN, BUTYLENE GLYCOL, SODIUM DILAURAMIDOGLUTAMIDE LYSINE, DISODIUM EDTA, ETHYLHEXYL PALMITATE, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/ DIMETHYLACRYLAMIDE CROSSPOLYMER, PHENOXYETHANOL, TITANIUM DIOXIDE (CI77891), TIN OXIDE (CI 77861), MICA (CI 77019) * HADASEI-3

QUESTIONS

Questions or Comments?

Call toll free (888) 739-2932 ext. 1

PRINCIPAL DISPLAY PANEL

TATCHA 

THE INDIGO CREAM

soothing skin protectant with colloidal oatmeal 

10 [50] ml/0.34 [1.7] fl. oz. 

INGREDIENTS AND APPEARANCE

THE INDIGO CREAM 
colloidal oatmeal 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69417-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
RICE BRAN (UNII: R60QEP13IC)
DOCOSANOL (UNII: 9G1OE216XY)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
INDIGOFERA TINCTORIA LEAF (UNII: 2K7DF8HZDM)
PERSICARIA TINCTORIA LEAF (UNII: FU6582QMPV)
OAT KERNEL OIL (UNII: 3UVP41R77R)
STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E)
RICE GERM OIL (UNII: D4H5GGS5JF)
COCONUT OIL (UNII: Q9L0O73W7L)
INOSITOL (UNII: 4L6452S749)
SERICIN 1 (UNII: N6466G03F7)
AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENETH-20 (UNII: BJ4GP2IFLN)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STANNIC OXIDE (UNII: KM7N50LOS6)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69417-120-17	1 in 1 BOX	08/02/2018
1		50 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69417-120-03	1 in 1 BOX	08/02/2018
2		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	08/02/2018

Labeler - TATCHA, Inc. (006811461)