Label: THE INDIGO CREAM- colloidal oatmeal 2% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 31, 2022

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  • 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. 

    Tatcha 10 mL PDP

    Tatcha 10 mL Panel

    Tatcha 50 mL PDP

    Tatcha 50 mL Panel

  • INGREDIENTS AND APPEARANCE
    THE INDIGO CREAM 
    colloidal oatmeal 2% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69417-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69417-120-171 in 1 BOX08/02/2018
    150 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69417-120-031 in 1 BOX08/02/2018
    210 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/02/2018
    Labeler - TATCHA, Inc. (006811461)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International, Inc.083913913manufacture(69417-120)
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