Label: 75 ALCOHOL WIPES- 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 21, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl alcohol 75%

    Purpose

    Antibacterial

  • Uses

    To decrease bacteria on the skin that could cause disease. Recommended to use repeatedly.

  • Warnings

    For external use only.

    please put in a cool and dry place avoid direct sunlight and very warm temperature.

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash appears and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Wet skin thoroughly with this products and allow to dry. Discard wipes in a recyclable trash can after use.

  • Inactive Ingredients

    Butane-1,3-diol, Glycerol, Pure water, Aloe extract

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    75 ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74341-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74341-019-0160 in 1 BAG07/10/2020
    15.41 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/10/2020
    Labeler - Newacme LLC (117465743)
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