The Indigo Calming Cream
FDA Label NDC 69417-140
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 Calming (NDC 69417-140). 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, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Colloidal Oatmeal 2%
Purpose
Skin Protectant
Uses
Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema
Warnings
For external use only. 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
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.
Directions
Apply as needed.
Inactive Ingredients
Water/Aqua, Squalane, Dimethicone, Propanediol, Glycerin, Diisostearyl malate, Oryza Sativa (Rice) Bran Wax, Behenyl Alcohol, Beheneth-20, Sorbitan Tristearate, Bis-diglyceryl Polyacyladipate-2, Inositol, Saccharomyces/Rice Ferment Filtrate, Camellia Sinensis Leaf Extract, Cladosiphon Okamuranus Extract, 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, Sericin, Tetrasodium Tetracarboxymethyl Naringeninchalcone, Caprylyl/Capryl Glucoside, Sorbitan Isostearate, Sodium Hyaluronate, Trihydroxystearin, Dimethicone/Vinyl dimethicone Crosspolymer, Ethylhexylglycerin, Butylene Glycol, Sodium Dilauramidoglutamide Lysine, Ethylhexyl Palmitate, Sodium Acrylate/Acryloyldimethyltaurate/Dimethylacrylamide Crosspolymer, Phenoxyethanol, Titanium Dioxide (CI 77891), Tin Oxide (CI 77861), Mica (CI 77019)
Questions?
Call toll-free (877) 322-8633
Packaging
Tatcha-140 (6941714003 1)
Tatcha-140 (6941714017 1)
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