Label: 12 HOUR MIRACLE- allantoin ointment

  • NDC Code(s): 61328-101-10, 61328-101-11, 61328-101-12, 61328-101-51
  • 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 September 14, 2018

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  • Active Ingredients

    Allantoin 0.5%

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  • Purpose

    Skin protectant

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  • Uses

    Restores and protects lips, cuticles and dry patches.

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  • Warnings

    For external use only.

    When using this product

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

    KEEP OUT OF REACH OF CHILDREN.

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  • Directions

    Apply as needed.

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  • 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.

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  • INGREDIENTS AND APPEARANCE
    12 HOUR MIRACLE 
    allantoin ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61328-101
    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:61328-101-51 1 in 1 BOX 05/23/2015
    1 NDC:61328-101-11 60 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:61328-101-10 10 g in 1 TUBE; Type 0: Not a Combination Product 03/15/2017
    3 NDC:61328-101-12 102 g in 1 TUBE; Type 0: Not a Combination Product 03/15/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 05/23/2015
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
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