Label: HAND SANITIZER- alcohol solution
HAND SANITIZER- alcohol solution

  • Contains inactivated NDC Code(s)
    NDC Code(s):     74161-175-01, 74161-175-02, 74161-175-03, 74161-175-04, view more
    74161-175-05, 74161-175-06, 74161-175-07, 74161-175-08, 74161-176-02, 74161-176-03, 74161-176-04, 74161-176-05, 74161-176-07, 74161-177-02, 74161-177-03, 74161-177-10, 74161-177-11
  • Packager: Solquim SA DE CV
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 14, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer 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

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    Deer Bottle 60ml

    Arroyo Bottle3 120 ml

    Arroyo Bottle2 120 ml

    Arroyo Bottle 120 ml

    Solquim Bottle 500 ml

    Solquim Bottle 120 ml

    Solquim Bottle 60 ml

    Solquim Drum 50000 ml

    Solquim Drum 20000 ml

    Solquim Bottle 4000 ml

    Solquim Bottle 1000 ml

    Drum 1000000 ml

    HEY bottlr 120 ml

    HEY bottle 4000 ml

    HEY bottle 60 ml

    HEY Bottle 1000 ml

    HEY bottle 500 ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74161-175
    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
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74161-175-0150000 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    2NDC:74161-175-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    3NDC:74161-175-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    4NDC:74161-175-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    5NDC:74161-175-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    6NDC:74161-175-044000 mL in 1 DRUM; Type 0: Not a Combination Product05/26/2020
    7NDC:74161-175-0620000 mL in 1 DRUM; Type 0: Not a Combination Product05/26/2020
    8NDC:74161-175-081000000 mL in 1 DRUM; Type 0: Not a Combination Product05/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74161-176
    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
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74161-176-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    2NDC:74161-176-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    3NDC:74161-176-044000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    4NDC:74161-176-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    5NDC:74161-176-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/08/2020
    HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74161-177
    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
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74161-177-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    2NDC:74161-177-10120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    3NDC:74161-177-11120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    4NDC:74161-177-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/08/2020
    Labeler - Solquim SA DE CV (821362605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Solquim S.A. de C.V.821362605manufacture(74161-175, 74161-176, 74161-177)
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