Label: 12 HOUR HEALING- allantoin ointment

  • 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 May 2, 2017

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Allantoin 0.5%

  • Purpose

    Skin protectant

  • Uses

    HELPS HEAL DRY, CHAPPED OR CRACKED SKIN. tEMPORARILY PROTECTS MINOR CUTS, SCRAPES, AND BURNS.

  • Warnings

    For external use only.

    When using this product

    • Avoid contact with eyes
  • WHEN USING

    WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • CONDITIONS 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.

  • Directions

    APPLY GENEROUSLY AS NEEDED TO IRRITATED OR AFFECTED SKIN.

  • OTHER INFORMATION

    STORE AT 65 - 80°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Beeswax, Bisabolol, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Petrolatum, Rosa Canina Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Cupuacu (Theobroma Grandiflorum) Seed Butter, Tocopherol.

  • PRINCIPAL DISPLAY PANEL

    Skinfix_12HR_US_4oz_V6_OL_R

  • INGREDIENTS AND APPEARANCE
    12 HOUR HEALING 
    allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SHEANUT OIL (UNII: O88E196QRF)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61328-116-11102 g in 1 TUBE; Type 0: Not a Combination Product05/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/02/2017
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)