Label: 75% ALCOHOL WIPES- alcohol wipes 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 20, 2020

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  • Active Ingredient(s)

    75% Alcohol

  • Purpose

    wipe

  • Use

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

  • Warnings

    To avoid risk of choking and suffocation,keep wipes,plastic bags and containers away from babies and children

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    1.open resealable packet and take out one wipe at a time

    2.after use,dispose of wipe in trash.do not flush down the toilet

    3.after cleaning,allow wetted surface to dry before use

    4.when finished,close lid tightly to preserve moisture

    5.store at room temperature

  • Other information

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

    non-weven fabric, reverse osmosis purified water

  • Package Label - Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL WIPES 
    alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78055-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78055-008-0150 in 1 BAG; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2020
    Labeler - Dalian Oupai Technology Co.,Ltd (529342302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Oupai Technology Co.,Ltd529342302manufacture(78055-008)
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