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 January 23, 2022

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

  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v.

  • Purpose

    Antiseptic

  • Use

    • For hand sanitizing that helps reduce bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    • For external use only.
    • Flammable, Keep away from fire or flame, heat, spark, electrical.
  • 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.
  • 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

    • Wipe the surface of the skin and let it air dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store at room temperature.
    • Keep pouch tightly closed and stored at room temperature.
    • Hold away from face when opening.
  • Inactive ingredients

    Water, Glycerol, Propane -1,2-diol, Benzalkonium Chloride, Aloe Vera Extract, Cetylpyridinium Chloride, Didecyldimethylammonium Chloride, Tea Tree Oil, Matricaria Recutita Extract, Quaternary, Citric Acid.

  • Package Label - Principal Display Panel

    10 PATCH in 1 PACKET NDC: 40562-009-01 10pcs label

    50 PATCH in 1 PACKET NDC: 40562-009-02

    40 PATCH in 1 PACKET NDC: 40562-009-03

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL WIPES 
    alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40562-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40562-009-0110 in 1 PACKET06/16/2020
    14 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:40562-009-0250 in 1 PACKET06/16/2020
    24 mL in 1 PATCH; Type 0: Not a Combination Product
    3NDC:40562-009-0340 in 1 PACKET07/16/2020
    34 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/16/2020
    Labeler - Anhui Hanbon Daily Chemical Co., Ltd. (405624856)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anhui Hanbon Daily Chemical Co., Ltd.405624856manufacture(40562-009)