The Indigo Cream
FDA Label NDC 69417-120

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tatcha, Inc. for the product The Indigo Cream (NDC 69417-120). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients

Colloidal Oatmeal 2%

Otc - 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

Otc - 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

Otc - 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

Otc - Questions

Questions or Comments?

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

Package Label.Principal Display Panel

TATCHA 

THE INDIGO CREAM

soothing skin protectant with colloidal oatmeal 

10 [50] ml/0.34 [1.7] fl. oz. 

* Please review the disclaimer below.