Label: SANITARY WIPES- didecyl dimethyl ammonium chloride cloth
75% ALCOHOL SANITARY WIPES- alcohol cloth

  • NDC Code(s): 81332-101-01, 81332-101-02, 81332-101-03, 81332-101-04, view more
    81332-101-05, 81332-101-06, 81332-101-07, 81332-101-08, 81332-101-09, 81332-101-10, 81332-102-01, 81332-102-02, 81332-102-03, 81332-102-04, 81332-102-05, 81332-102-06, 81332-102-07, 81332-102-08, 81332-102-09, 81332-102-10
  • Packager: Shandong Green Huineng Technology Co., Ltd.
  • 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 June 19, 2023

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  • SPL UNCLASSIFIED SECTION

    75% alcohol sanitary wipes

    Sanitary wipes

  • Active Ingredient(s)

    75% alcohol sanitary wipes: Alcohol 3.15mL/pcs. Purpose: Antiseptic

    Sanitary wipes: Didecyl dimethyl ammonium chloride 0.00168mg/pcs; benzalkonium chloride 0.00189mg/pcs Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    75% alcohol sanitary wipes, Sanitary wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

  • Do not use

    • in 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 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

    • Wipe the surface of the skin and let it dry naturally.
    • Supervise children under 6 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

    75% alcohol sanitary wipes:

    WATER


    Sanitary wipes:

    WATER

  • Package Label - Principal Display Panel

    101-1101-2102-1102-2

  • INGREDIENTS AND APPEARANCE
    SANITARY WIPES 
    didecyl dimethyl ammonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81332-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.00168 mg
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.00189 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81332-102-0150 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    2NDC:81332-102-0280 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    3NDC:81332-102-03100 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    4NDC:81332-102-04150 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    5NDC:81332-102-05200 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    6NDC:81332-102-06250 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    7NDC:81332-102-07300 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    8NDC:81332-102-08500 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    9NDC:81332-102-09800 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    10NDC:81332-102-101200 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/22/2020
    75% ALCOHOL SANITARY WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81332-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81332-101-0150 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    2NDC:81332-101-0280 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    3NDC:81332-101-03100 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    4NDC:81332-101-04150 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    5NDC:81332-101-05200 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    6NDC:81332-101-06250 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    7NDC:81332-101-07300 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    8NDC:81332-101-08500 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    9NDC:81332-101-09800 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    10NDC:81332-101-101200 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/22/2020
    Labeler - Shandong Green Huineng Technology Co., Ltd. (554553759)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Green Huineng Technology Co., Ltd.554553759manufacture(81332-101, 81332-102)
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