Label: 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 January 27, 2022

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  • Active Ingredient(s)

    Alcohol, 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Uses

    To help reduce the risk of disease and minimize germs and bacteria when hand washing is not readily available.

  • Warnings

    Only use externally. This product is flammable, so please keep away from heat or open flame.

    Avoid use on cuts or broken skin, children under the age of 2 months, or around the eyes.

    If you have skin allergies, check ingredients before use.

    May cause inflammation to sensitive skin, discontinue use if rash or discoloration occurs. Wash off immediately with lots of water. Cosult immediate medical attention if problem persist.

  • DO NOT USE

    Avoid use on cuts or broken skin, children under the age of 2 months, or around the eyes.

    If you have skin allergies, check ingredients before use.

  • WHEN USING

    Avoid use on cuts or broken skin, children under the age of 2 months, or around the eyes.

    If you have skin allergies, check ingredients before use.

  • STOP USE

    May cause inflammation to sensitive skin, discontinue use if rash or discoloration occurs. Wash off immediately with lots of water. Cosult immediate medical attention if problem persist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions for Use

    Pull adhesive opening tab back, then pull each wipe out seareately as needed.

    To close, press adhesive tab down with finger to keep each wipe moist for the next use.

  • Other information

    If kept in a cool, dry place, there is a 2-year sustainable shelf life while packet is unopen.

    Otherwise, warm temperatures can cause a diminished shelf life or dry out wipes.

    Additionally, some fabrics and wood surfaces may discolor.

  • Inactive Ingredient(s)

    Aloe Vera, Water, Lemon

  • Package Label - Principal Display Panel

    L101-03

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82534-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82534-101-0330 in 1 PACKET; Type 0: Not a Combination Product01/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/27/2022
    Labeler - Hangzhou Beite Daily Necessities Co., Ltd. (713301066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Beite Daily Necessities Co., Ltd.713301066manufacture(82534-101)
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