Label: SANITIZER WIPES- ethyl alcohol solution

  • 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 27, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v.

  • Purpose

    Purpose: Antimicrobial

  • Use

    Sanitizer Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • On children less than 2 months of age
    • On open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, 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.

  • Directions

    Wipe surface to be disinfected.

    Supervise children under 12 years of age when using this product to avoid swallowing.

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water Glycerol, Aloe. Vera, Chamomile Oil, D-Glucopyranose, Oligomeric, Benzethonium Chloride, Cetylpyridinium Chloride, Didecyldimethylammonium Chloride

  • Package Label - Principal Display Panel

    300 units NDC:75778-004-30

    300 Wipes

  • INGREDIENTS AND APPEARANCE
    SANITIZER WIPES 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75778-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 0.1 
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S) 0.05 
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) 0.04 
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.3 
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) 0.2 
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) 0.08 
    WATER (UNII: 059QF0KO0R) 23.73 
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75778-004-30300 in 1 CARTON; Type 0: Not a Combination Product05/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2020
    Labeler - Audy Global Enterprises Inc. (079171473)
    Establishment
    NameAddressID/FEIBusiness Operations
    ENPING JIAXIN DAILY NECESSITIES CO.,LTD.403010421manufacture(75778-004)
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