Label: 75% ALCOHOL WET 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 January 18, 2021

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

  • Active Ingredient(s)

    75%ethyl alcohol by volume....antimicrobial

  • Purpose

    antimicrobial

  • Use

    Use to help reduce bacterial on skin.

  • Warnings

    Flammable.External use only

    Do not use on open skin wounds or children under 2 months of age

    When using this product avoid contact with eyes.If case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Do not use

    Do not use on open skin wounds or children under 2 months of age

  • WHEN USING

    When using this product avoid contact with eyes.If case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

    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 develops and continues for more than 72 hours.

  • 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

    ·for initial use, rotate and take off lid, cut a hole in middle of foil seal, pull out one wipe, run through lid, rotate lid back to canister, open flip-up lid, and take out wipes for use.
    ·Discard used wipe in trash, do not flush.

  • Other information

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

    aloe barbadensis leaf juice, glycerin, purified water, propylene glycol, tocopheryl acetate.

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    81422-001-00--Alcohol Wet Wipes 100wipes

    81422-001-00--Alcohol Wet Wipes 100wipes

    81422-001-01--Alcohol Wet Wipes 1 wipe

    81422-001-01--Alcohol Wet Wipes 1 wipe

    81422-001-10--Alcohol Wet Wipes 10wipes

    81422-001-10--Alcohol Wet Wipes 10wipes

    81422-001-60--Alcohol Wet Wipes 60wipes

    81422-001-60--Alcohol Wet Wipes 60wipes

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL WET WIPES 
    75% alcohol wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81422-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81422-001-00100 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:81422-001-1010 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:81422-001-011 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    4NDC:81422-001-6060 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Shenzhen Lynns Industrial Co., Ltd. (525563756)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lynns Industrial Co., Ltd.525563756manufacture(81422-001)