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| Product NDC Code | 69417-140 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | The indigo calming |
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| Type | Brand | ||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 1189915 | ||||||
| Application Number | part347 | ||||||
| Labeler Name | TATCHA INC. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Colloidal Oatmeal 2%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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)
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.THE INDIGO CALMING Colloidal Oatmeal OATMEAL OATMEAL WATER SQUALANE DIMETHICONE PROPANEDIOL GLYCERIN DIISOSTEARYL MALATE RICE BRAN BEHENETH-20 SORBITAN TRISTEARATE BIS-DIGLYCERYL POLYACYLADIPATE-2 INOSITOL GREEN TEA LEAF CLADOSIPHON OKAMURANUS INDIGOFERA TINCTORIA LEAF OAT STYPHNOLOBIUM JAPONICUM FLOWER RICE GERM OIL COCONUT OIL SILK SERICIN CAPRYLYL/CAPRYL OLIGOGLUCOSIDE SORBITAN ISOSTEARATE HYALURONATE SODIUM TRIHYDROXYSTEARIN DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) ETHYLHEXYLGLYCERIN BUTYLENE GLYCOL SODIUM DILAURAMIDOGLUTAMIDE LYSINE ETHYLHEXYL PALMITATE PHENOXYETHANOL TITANIUM DIOXIDE STANNIC OXIDE MICA
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging Tatcha-140 Tatcha-140
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
soothing skin protectant Reveal calm, smooth skin with our rich, fragrance-free moisturizer. This treatment contains Japanese indigo and delivers therapeutic colloidal oatmeal to provide soothing relief of redness and itchiness. FORMULATED IN JAPAN MADE IN USA DIST. TATCHA LLC SAN FRANCISCO, CA 94123 USA UK: DELPHIC HSE GU14 7NA NL: 104 SCHIPHOL, 1118CN © 2023 TATCHA LLC TATCHA.COM BEAUTIFUL FACES, BEAUTIFUL FUTURES Your purchase supports education equality www.tatcha.com/giving-back
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll-free (877) 322-8633
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API