Label: MAPLE CROSS 75 ISOPROPYL ANTIBACTERIAL- isopropyl alcohol cloth

  • 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 7, 2020

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

  • Drug Facts:

  • Medicinal / Active ingredient:

    Isopropyl alcohol 75% v/v

    Purpose:

    Antiseptic

  • Non medicinal / Inactive ingredients:

    Water (Aqua). This product does not contain mercury.

  • Indications:

    Medicated (skin) cleanser. Effective in destroying (harmful) bacteria to provide  antiseptic cleansing.

  • 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:77216-003-01

    Label

  • Package Labeling:77216-003-02

    Label2

  • INGREDIENTS AND APPEARANCE
    MAPLE CROSS 75 ISOPROPYL ANTIBACTERIAL 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77216-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77216-003-0150 in 1 CANISTER07/15/2020
    13 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:77216-003-02100 in 1 CANISTER07/15/2020
    23 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/15/2020
    Labeler - Maple Cross Health Inc. (204125678)