Label: 911- allantoin ointment

  • NDC Code(s): 61328-120-11, 61328-120-12
  • 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 December 24, 2022

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  • Active Ingredients

    Allantoin 0.5%

  • Purpose

    Skin protectant

  • Uses

    Restores and protects lips, cuticles and dry patches.

  • Warnings

    For external use only.

    When using this product

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

    KEEP OUT OF REACH OF CHILDREN.

  • Directions

    Apply as needed.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Skinfix_US_911_Ointment_BOX_V4_R - box

  • INGREDIENTS AND APPEARANCE
    911 
    allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-120
    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:61328-120-1150 g in 1 TUBE; Type 0: Not a Combination Product12/26/2018
    2NDC:61328-120-128.5 g in 1 TUBE; Type 0: Not a Combination Product12/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/26/2018
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Company207062514manufacture(61328-120)
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