Label: ALCOHOL WET WIPE gel
HAND SANITIZER- hand sanitizer gel gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     54237-030-01, 54237-030-02, 54237-030-03, 54237-030-04, view more
    54237-030-05, 54237-030-06, 54237-030-07, 54237-030-08, 54237-030-09, 54237-030-10, 54237-030-11, 54237-030-12, 54237-030-13, 54237-031-01, 54237-031-02, 54237-031-03, 54237-031-04, 54237-031-05, 54237-031-06, 54237-031-07, 54237-031-08, 54237-031-09
  • Packager: Guangzhou Daieme Cosmetic Co,.Ltd
  • Category: HUMAN OTC DRUG LABEL

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 February 2, 2021

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  • Main active ingredient

    70%(v/v) ethanol

  • SPL UNCLASSIFIED SECTION

    • THIS ITEM HAS DISINFECTION FUNCTION, CONVENIENT USE TO KILL 99.9% OF GERMS.
    • Effective for germs like: colibasillus. Candida albicans anc Staphylococcus aureus.
    • Scope of application: hands cleaning and disifection.
    • Main active ingredient: 70%(V/V)ethanol
    • Ingredients: water, EDTA disodium, carbomer, triethanolamine, ethyalcohol.
    • Usage: for hands disinfection, take out about 2ml of gel, rub it on the skin for 1 minute, it can be dry without washing. Repeated use make a slight sticky feeling, please wash with water.
    • Notice: Flammable, please keep it away from fire.Please store it in an environment below 50℃.external used, don't take it by mouth, and don't contact with the eyes directly, once contacting with eyes,please wash eyes with plenty of clean water quickly. Please close it well after use to avoid volatilization.Take caution if you are allergic to alcohol.
    • Period of validity: 2 years
  • Scope of application

    Hands cleaning and disifection

  • Usage

    for hands disinfection, take out about 2ml of gel, rub it on the skin for 1 minute, it can be dry without washing. Repeated use make a slight sticky feeling, please wash with water.

  • Notice

    Flammable, please keep it away from fire.Please store it in an environment below 50℃.external used, don'ttake it by mouth, and don't contact with the eyes directly, once contacting with eyes,please wash eyes with plenty of clean water quickly. Please close it well after use to avoid volatilization.Take caution if you are allergic to alcohol.

  • Do not use

    • Avoid contacting with eyes, and damaged skin
  • WHEN USING

    Flammable, please keep it away from fire.Please store it in an environment below 50°c.external used, don'ttake it by mouth, and don't contact with the eyes directly, once contacting with eyes,please wash eyes with plenty of clean water quickly. Please close it well after use to avoid volatilization.Take caution if you are allergic to alcohol.

  • STOP USE

    Take caution if you are allergic to alcohol.

  • KEEP OUT OF REACH OF CHILDREN

    Keep our of reach of children. Avoid contacting with eyes, and damaged skin

  • Directions

    Avoid contacting with eyes, and damaged skin

  • Other information

    • Please store it in an environment below 50 ℃
  • ingredients

    water, EDTA disodium, carbomer, triethanolamine, ethyl alcohol.

  • Package label

    gel labelWipes label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WET WIPE 
    alcohol wet wipe gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54237-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) 0.5 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54237-031-011 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:54237-031-028 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:54237-031-0310 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    4NDC:54237-031-0420 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    5NDC:54237-031-0525 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    6NDC:54237-031-0648 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    7NDC:54237-031-0750 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    8NDC:54237-031-0880 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    9NDC:54237-031-09100 mL 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
    HAND SANITIZER 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54237-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK) 0.28 mL  in 100 mL
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.01 mL  in 100 mL
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) 0.28 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54237-030-012 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    2NDC:54237-030-0230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    3NDC:54237-030-0360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    4NDC:54237-030-0499 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    5NDC:54237-030-05100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    6NDC:54237-030-06120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    7NDC:54237-030-07300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    8NDC:54237-030-08500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    9NDC:54237-030-091000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    10NDC:54237-030-1029.57 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    11NDC:54237-030-11118.28 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    12NDC:54237-030-12236.56 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    13NDC:54237-030-13473.12 mL in 1 BOTTLE, PLASTIC; 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 - Guangzhou Daieme Cosmetic Co,.Ltd (542359812)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Daieme Cosmetic Co,.Ltd542359812manufacture(54237-030, 54237-031)
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