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
  • 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 September 14, 2018

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

  • 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

    01b LBL_12-Hour Miracle Ointment_V18

  • INGREDIENTS AND APPEARANCE
    12 HOUR MIRACLE 
    allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-101
    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:61328-101-511 in 1 BOX05/23/2015
    1NDC:61328-101-1160 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:61328-101-1010 g in 1 TUBE; Type 0: Not a Combination Product03/15/2017
    3NDC:61328-101-12102 g in 1 TUBE; Type 0: Not a Combination Product03/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/23/2015
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)