Label: FIRST AID BEAUTY FAB ULTRA REPAIR BODY SKIN PROTECTANT- colloidal oatmeal lotion

  • NDC Code(s): 69423-726-28
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 11, 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, glycerin, C12-15 alkyl benzoate, stearic acid, caprylic/capric triglyceride glyceryl stearate, glyceryl atearate SE, butyrospermum parkii (shea) butter, dimethicone, squalane, phenoxyethanol, allantoin, camellia sinensis leaf extract, caprylyl glycol, ceramide NP, cetearyl alcohol, chrysanthemum parthenium (feverfew) extract, disodium EDTA, glycyrrhiza glabra (licorice) root extract, sodium hydroxide, tetrasodium EDTA, xanthan gum

  • Questions:

    888-FAB-3063

  • SPL UNCLASSIFIED SECTION

    MADE IN USA

    FIRST AID BEAUTY LTD

    NEWTON, MA 02458

    WWW.FIRSTAIDBEAUTY.COM

  • PRINCIPAL DISPLAY PANEL - 283.5 g (10 oz)

    First Aid Beauty

    FAB

    Ultra Repair Body Lotion

    Lightweight, Daily Hydration

    Skin Protectant Colloidal Oatmeal

    Net Wt. 283.5 g (10 oz)

    FAB

  • INGREDIENTS AND APPEARANCE
    FIRST AID BEAUTY FAB ULTRA REPAIR BODY SKIN PROTECTANT 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-726
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CERAMIDE NP (UNII: 4370DF050B)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-726-28283.5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/15/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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