911 BALM-C (ALLANTOIN) OINTMENT [SKINFIX, INC.]

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911 BALM-C (ALLANTOIN) OINTMENT [SKINFIX, INC.]
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NDC 61328-118-11, 61328-118-51
Set ID 2e6a2b07-1fa7-45b1-ba69-66c689533fe8
Category HUMAN OTC DRUG LABEL
Packager Skinfix, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredients

    Allantoin 1%

  • Purpose

    Skin protectant

  • Uses

    Helps prevent and temporarily protects chafed, chapped or cracked skin and lips. Temporarily protects minor

    • cuts
    • scrapes
    • burns.
  • 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.
  • 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.

  • Directions

    Apply to affected areas as needed.

  • OTHER INFORMATION

    STORE AT 65-75°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.

  • Inactive Ingredients

    Beeswax, Butyrospermum Parkii (Shea) Butter, Colloidal Oatmeal, Glycine Soja (Soybean) Oil, Paraffin, Petrolatum, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol.

  • QUESTIONS?

    1.866.927.2783

  • PRINCIPAL DISPLAY PANEL

    Skinfix_911_C_Balm_BOX_V7

    Skinfix_911_C_Balm_D19_90mm_V10

  • INGREDIENTS AND APPEARANCE
    911 BALM-C 
    allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OATMEAL (UNII: 8PI54V663Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61328-118-511 in 1 BOX08/11/2018
    1NDC:61328-118-1113.5 g in 1 TUBE; Type 0: Not a Combination Product
    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)
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