Label: FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT VANILLA CINNAMON- colloidal oatmeal cream

  • NDC Code(s): 84126-048-01, 84126-048-39
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 21, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Colloidal Oatmeal 0.5%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites
  • Warnings

    For external use only.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    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

  • Directions

    Apply as needed

  • INACTIVE INGREDIENT

    Water, stearic acid, glycerin, C12-15 alkyl benzoate, caprylic /capric, triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalane, phenoxyethanol, caprylyl glycol, xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, cocos nucifera (coconut) fruit extract, ricinus communis (castor) seed oil, vanillin, ethyl butyrate, ethyl hydroxypyrone, acetoin, phenethyl acetate, methyl 2-phenylacetate,dimethylhydroxy furanone, methylcyclopentenolone, delta decalactone

  • Questions:

    888-FAB-3063

  • SPL UNCLASSIFIED SECTION

    MADE IN USA

    FIRST AID BEAUTY LTD

    NEWTON, MA 02458

    WWW.FIRSTAIDBEAUTY.COM

  • PRINCIPAL DISPLAY PANEL - 396.8 g (14 oz)

    First Aid Beauty

    FAB

    Ultra Repair® Cream

    Intense Hydration

    Skin Protectant Colloidal Oatmeal

    VANILLA CINNAMON

    Net Wt. 396.8 g (14 oz)

    FAB

  • INGREDIENTS AND APPEARANCE
    FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT VANILLA CINNAMON 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84126-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    VANILLIN (UNII: CHI530446X)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    ETHYL HYDROXYPYRONE (UNII: L6Q8K29L05)  
    ACETOIN (UNII: BG4D34CO2H)  
    RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)  
    PHENETHYL ACETATE (UNII: 67733846OW)  
    DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLCYCLOPENTENOLONE (UNII: 627E92X64B)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TETRASODIUM EDTA (UNII: MP1J8420LU)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CERAMIDE NP (UNII: 4370DF050B)  
    TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)  
    COCOS NUCIFERA (COCONUT) FRUIT EXTRACT (UNII: 3RT3536DHY)  
    METHYL PHENYLACETATE (UNII: D4PDC41X96)  
    DELTA-DECALACTONE (UNII: CNA0S5T234)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84126-048-39396.8 g in 1 JAR; Type 0: Not a Combination Product10/01/2024
    2NDC:84126-048-012 in 1 PACKAGE10/01/2024
    2396.8 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/01/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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