Label: MIRACLE HEALTH HAND SANITIZER- isopropyl alcohol gel

  • 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 July 9, 2020

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  • Active Ingredient

    Isopropyl Alcohol 70% v/v.

  • Purpose

    Antimicrobial

  • Use

    Helps reduce bacteria and viruses on the skin that could cause disease. Recommended for repeated use. Do not ingest, for topical use only.

  • Warnings

    Flammable. Keep away from heat or flame. For external use only.

    Stop use and see doctor if irritation or rash appears/lasts.
    When using this product do not use in or near the eyes. In case of contact rinse eyes thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a poison control Center right away, not recommended for infants.

  • Directions

    • Place enough product in your palm to cover hands. Rub hand together until dry.
    • Children under 6years of age should be supervised when using this product.
  • Other information

    • Do not store above 110 F (43C).
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Acrylates/C10 Alkyl Acrylate, Aloe Barbadensis Leaf Juice, Glycerin, Tocopherol Acetate, Lavendula Lalifolia, Triethanolamine

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    MIRACLE HEALTH HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79668-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVANDULA LATIFOLIA WHOLE (UNII: 45396ETX3Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79668-001-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/16/2020
    2NDC:79668-001-02118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/16/2020
    3NDC:79668-001-03236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/16/2020
    4NDC:79668-001-04473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/16/2020
    5NDC:79668-001-05946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/16/2020
    6NDC:79668-001-063785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/16/2020
    Labeler - K W TECHNOLOGY INC (129513852)
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