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%

  • 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)