Label: 911- allantoin ointment

  • NDC Code(s): 61328-120-11, 61328-120-12, 61328-120-13
  • Packager: Skinfix, Inc.
  • 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 17, 2019

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

  • Active Ingredients

    Allantoin 0.5%

    Close
  • Purpose

    Skin protectant

    Close
  • Uses

    Restores and protects lips, cuticles and dry patches.

    Close
  • Warnings

    For external use only.

    When using this product

    • Avoid contact with eyes
    Close
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    Close
  • Directions

    Apply as needed.

    Close
  • Inactive Ingredients

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

    Close
  • INGREDIENTS AND APPEARANCE
    911 
    allantoin ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61328-120
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61328-120-11 50 g in 1 TUBE; Type 0: Not a Combination Product 12/26/2018
    2 NDC:61328-120-12 8.5 g in 1 TUBE; Type 0: Not a Combination Product 12/26/2018
    3 NDC:61328-120-13 102 g in 1 TUBE; Type 0: Not a Combination Product 05/17/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 12/26/2018
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
    Close