Label: MAPLE CROSS 80 ETHANOL HAND SANITIZER- alcohol liquid

  • 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 May 11, 2020

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  • Drug Facts:

  • Medicinal / Active ingredient:

    Ethyl alcohol 80% v/v

    Purpose:

    Antiseptic

  • Non medicinal / Inactive ingredients:

    Water (Aqua), Glycerin, Hydrogen peroxide, Denatonium benzoate. This product does not contain mercury.

  • Indications:

    For personal hand hygiene to help prevent the spread of bacteria.

  • Directions:

    Rub thoroughly into hands for at least 30 seconds. Allow to dry. For occasional and personal domestic use. Supervise children when they use this product.

  • Warning:

    Flammability warning. Keep away from open flame and sources of heat. For external use only.

    Keep out of reach of children.

    If swallowed, call a poison control centre or get medical help right away.

    Stop use and ask/ consult a doctor/physician/

    health care practitioner/ health care provider/ health care professional if irritation develops.

    When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • Contraindications:

    Do not use on children/infants less than 2 years of age (unless directed by a doctor/ physician/ health care practitioner/ health care provider/ health care professional).

  • Other information:

    Store below 110°F (43°C). May discolour certain fabrics or surfaces.

  • Package Labeling: 300ml

    Label

  • Package Labeling: 500ml

    Label2

  • Package Labeling: 1000ml

    Label3

  • INGREDIENTS AND APPEARANCE
    MAPLE CROSS 80 ETHANOL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77216-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77216-000-00300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    2NDC:77216-000-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    3NDC:77216-000-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Maple Cross Health Inc. (204125678)
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