Label: MIRACLE HEEL REPAIR- allantoin , dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 18, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient : Allantoin 1.0 % , Dimethicone 1.0 %

  • PURPOSE

    Purpose : Skin Protectant


  • WARNINGS

    Warnings: For external use only .

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children : In case of accidental ingestion, get medical help or contact a Poison Control center right away.


  • DOSAGE & ADMINISTRATION

    Directions :  adults and  children 2 years and older apply as needed

                          under 2 years ask a doctor.

                          wash and dry skin apply liberatly over attached area and massage until absorbed .





  • INDICATIONS & USAGE

    Uses: Temporary protects and helps relieve chapped or cracked skin


  • INACTIVE INGREDIENT

    aloe barabardensis leaf Juice , water , PEG 8, stearic acid , PEG-100 stearte , glyceryl stearate , cetearyl alcohol, polysorbate 60 , propylene glycol, mineral oil ,hydrogenated polyisobutene,cetyl alcohl , butyrospermum parkii (shea butter) , theobroma cacao (cocoa) seed butter , triethanolamine, mangifera indica (mango) seed butter, salicylic acid ,chondrus crispis (carageenan) , arthemis nobilis flower extract, fragrance, methylparaben, propylparaben,  tetrasodium edta , bht, diazolidinyl urea



  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MIRACLE HEEL REPAIR  
    allantoin , dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66391-0604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin 1.12 g  in 112 g
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 1.12 g  in 112 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Water (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    MANGO (UNII: I629I3NR86)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CHONDRUS (UNII: XR12Z4HLEA)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66391-0604-0112 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34703/16/2009
    Labeler - Winning Solutions (962718300)
    Registrant - Beautymanufacturing Solutions Corperation (783200723)
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