Label: 911 BALM-C- allantoin ointment

  • NDC Code(s): 61328-118-11, 61328-118-51
  • Packager: Skinfix, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 August 13, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Allantoin 1%

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  • Purpose

    Skin protectant

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  • Uses

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

    • cuts
    • scrapes
    • burns.
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  • 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.
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  • 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.

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  • Directions

    Apply to affected areas as needed.

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  • OTHER INFORMATION

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

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  • 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.

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  • QUESTIONS?

    1.866.927.2783

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  • INGREDIENTS AND APPEARANCE
    911 BALM-C 
    allantoin ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61328-118
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61328-118-51 1 in 1 BOX 08/11/2018
    1 NDC:61328-118-11 13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 02/27/2017
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
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