BABY GENTLE ECZEMA PLUS SOOTHING BODY (COLLOIDAL OATMEAL) CREAM [SKINFIX, INC.]

  • Home
  • BABY GENTLE ECZEMA PLUS SOOTHING BODY (COLLOIDAL OATMEAL) CREAM [SKINFIX, INC.]

BABY GENTLE ECZEMA PLUS SOOTHING BODY (COLLOIDAL OATMEAL) CREAM [SKINFIX, INC.]
PDF | XML
NDC 61328-113-12
Set ID b1a10e8d-3312-4578-8874-cc4b906259c4
Category HUMAN OTC DRUG LABEL
Packager Skinfix, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
View All Sections
  • Active Ingredients

    Colloidal Oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

  • Warnings

    For external use only.

    When using this product

    • Avoid contact with 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.

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

  • Directions

    Apply generously to affected areas, especially after bathing.

  • Other Information

    Store at 65-80o F. May stain fabrics.

  • Inactive Ingredients

    allantoin, aloe barbadensis leaf juice, avena sativa (oat) extract, avena sativa (oat) kernel oil, caprylic/capric triglyceride, caprylyl caprylate/caprate citric acid, cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) extract, helianthus annuus (sunflower) seed oil, oryza sativa (rice) bran extract, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, vitis vinifera (grape) seed oil, water/aqua, xanthan gum.

  • PRINCIPAL DISPLAY PANEL

    US_Gentle_Eczema_Body_Cream_6oz.jpg

  • INGREDIENTS AND APPEARANCE
    BABY GENTLE ECZEMA PLUS SOOTHING BODY 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-4 STEARATE (UNII: VLC3W3U1PE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ROSEMARY (UNII: IJ67X351P9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61328-113-12177 mg in 1 TUBE; Type 0: Not a Combination Product02/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/27/2017
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
View All Sections

Related Drugs

Search DailyMed Drugs