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

  • NDC Code(s): 69423-565-39, 69423-565-56
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 February 9, 2023

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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, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, triethyl citrate, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, cinnamomum camphora linalooliferum wood extract, citrus limon (lemon) peel extract, punica granatum seed extract, rubus idaeus (raspberry) fruit extract, vaccinium macrocarpon (cranberry) seed oil, ceramide NP, ananas sativus (pineapple) fruit extract, citrus paradisi (grapefruit) peel extract, cucumis melo (melon) fruit extract, passiflora incarnata fruit extract, pimpinella anisum (anise) fruit extract, pyrus malus (apple) fruit extract, rosa damascene flower extract, Theobroma cacao (cocoa) extract, tsuga canadensis oil, vaccinium macrocarpon (cranberry) fruit extract, vanilla planifolia fruit extract

  • Questions:

    888-FAB-3063

  • SPL UNCLASSIFIED SECTION

    MADE IN USA

    FIRST AID BEAUTY LTD

    NEWTON, MA 02458

    WWW.FIRSTAIDBEAUTY.COM

  • PRINCIPAL DISPLAY PANEL - 14.0 oz (396.8 g)

    First Aid Beauty

    FAB

    Ultra Repair® Cream

    Intense Hydration

    Skin Protectant Colloidal Oatmeal

    Cranberry Pomegranate Natural Infusion

    Net Wt. 14.0 oz (396.8 g)

    FAB

  • INGREDIENTS AND APPEARANCE
    FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT CRANBERRY POMEGRANATE 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-565
    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
    TSUGA CANADENSIS LEAF OIL (UNII: Q1S51LGQ0G)  
    MUSKMELON (UNII: ZV095H5633)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    APPLE (UNII: B423VGH5S9)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    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)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    CERAMIDE NP (UNII: 4370DF050B)  
    VANILLA BEAN (UNII: Q74T35078H)  
    RASPBERRY (UNII: 4N14V5R27W)  
    LEMON PEEL (UNII: 72O054U628)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
    ANISE (UNII: 21C2F5E8RE)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    COCOA (UNII: D9108TZ9KG)  
    POMEGRANATE SEED (UNII: 7294Z34NS7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-565-39396.8 g in 1 JAR; Type 0: Not a Combination Product01/01/2023
    2NDC:69423-565-5656 g in 1 TUBE; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01601/01/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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