Label: NON-WASH DISINFECTANT- alcohol liquid
NON-WASH SANITISERGEL- alcohol liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    74457-101-01, 74457-101-02, 74457-101-03, 74457-101-04, view more
    74457-101-05, 74457-101-06, 74457-101-07, 74457-101-08, 74457-101-09, 74457-101-10, 74457-101-11, 74457-201-01, 74457-201-02, 74457-201-03, 74457-201-04, 74457-201-05, 74457-201-06, 74457-201-07, 74457-201-08, 74457-201-09, 74457-201-10, 74457-201-11
  • Packager: Shera Heman Zhejiang Biotechnologies 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 December 23, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Non-wash Disinfectant;
    Non-wash Sanitiser Gel

  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Non-wash Disinfectant, Non-wash Sanitiser Gel to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • 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

    Non-wash Disinfectant:

    purified water USP

    Non-wash Sanitiser Gel:

    WATER
    CARBOMER
    GLYCERIN

  • Package Label - Principal Display Panel

    101201

  • INGREDIENTS AND APPEARANCE
    NON-WASH DISINFECTANT 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74457-101
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74457-101-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    2NDC:74457-101-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    3NDC:74457-101-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    4NDC:74457-101-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    5NDC:74457-101-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    6NDC:74457-101-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    7NDC:74457-101-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    8NDC:74457-101-081000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    9NDC:74457-101-094000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    10NDC:74457-101-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    11NDC:74457-101-1125000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/24/2020
    NON-WASH SANITISERGEL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74457-201
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74457-201-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    2NDC:74457-201-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    3NDC:74457-201-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    4NDC:74457-201-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    5NDC:74457-201-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    6NDC:74457-201-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    7NDC:74457-201-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    8NDC:74457-201-081000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    9NDC:74457-201-094000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    10NDC:74457-201-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    11NDC:74457-201-1125000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/24/2020
    Labeler - Shera Heman Zhejiang Biotechnologies Co.,Ltd. (554528847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shera Heman Zhejiang Biotechnologies Co.,Ltd.554528847manufacture(74457-101, 74457-201)