12 HOUR MIRACLE (ALLANTOIN) OINTMENT [SKINFIX, INC.]

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12 HOUR MIRACLE (ALLANTOIN) OINTMENT [SKINFIX, INC.]
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NDC 61328-101-10, 61328-101-11, 61328-101-12, 61328-101-51
Set ID c8ee66c9-6d30-49ad-9965-12692551ead4
Category HUMAN OTC DRUG LABEL
Packager Skinfix, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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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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