Label: HAND SANITIZER- ethanol alcohol gel
HAND SANITIZING WIPES- ethanol alcohol 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 July 8, 2020

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  • 5L NDC:79032-202-50

    Retail Label 5L

    79032-202-51 Outer Carton Image

    Hand Sanitizer Gel Bidon 5L Quantite: 4tite

    Inactive Ingredients

    Water, Carbomer, Parfum, Triethanolamine, Glycerin, Heterotheca Inuloides Flower Extract

    Active ingredient - Alcohol

    Active Biocidal substance with % m/m: Ethanol (CAS N 64-175-) 56%

    Purpose

    Hydro-Alcoholic gel for hands decontamination, containing a hand-protecting agent. Its gel-texture allows a fast, practical, and effective use if the product disinfecting solution no foaming, without rinsing, nor wiping, without residues, eliminates the odors of bacterial proliferation.

    Dosage

    Apply the does of gel (1ml) on hands and scrub until hands are dry. Do not rinse

    Usage

    Apply the dose of gel (1 ml) on hands and scrub imtil the hands are dry. Do not rinse

    Warnings - Flammable

    Highly flammable liquid and vapor. Causes serious eye irritation. if medical advise is needed have product contianer or label at hand. Before use, read the label and information concerningthe product. Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources. No smoking, store in well ventilated place. Keep cool. Dispose of the contents in apporopriate collectors in accordance with local/regional/national/international regulations.

    Warnings - Biocide

    Danger: Biocode TP1 and TP2: ready to use alcohol-based and scented hand sanitizer.

    Active biocidal substance with % m/m: ethanol(CAS N 64-17-5) 56% Inventory number:38424

    Keep out of reach of Children

    Keep out of reach of Children

    Discontinue use

    If irritation occurs, discontinue use

  • 1L NDC 79032-213-11

    Retail Label

    Outer Carton Image - 79032-213-11

    Hand Sanitizer Gel Flacon 1L Quantite:12

    Inactive Ingriedients

    Water, Carbomer, Parfum, Triethanolamine, Glycerin, Heterotheca Inuloides Flower Extract

    Active Ingredients

    Active Biocidal substance with % m/m: Ethanol (CAS N 64-175-) 56%

    Purpose

    Hydro-Alcoholic gel for hands decontamination, containing a hand-protecting agent. Its gel-texture allows a fast, practical, and effective use if the product disinfecting solution no foaming, without rinsing, nor wiping, without residues, eliminates the odors of bacterial proliferation.

    Dosage

    Apply the does of gel (1ml) on hands and scrub until hands are dry. Do not rinse

    Usage

    Apply the dose of gel (1 ml) on hands and scrub imtil the hands are dry. Do not rinse

    Warning - Flammable

    Highly flammable liquid and vapor. Causes serious eye irritation. if medical advise is needed have product contianer or label at hand. Before use, read the label and information concerningthe product. Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources. No smoking, store in well ventilated place. Keep cool. Dispose of the contents in apporopriate collectors in accordance with local/regional/national/international regulations.

    Warning - Biocide

    Danger: Biocode TP1 and TP2: ready to use alcohol-based and scented hand sanitizer.

    Active biocidal substance with % m/m: ethanol(CAS N 64-17-5) 56% Inventory number:38424

    Keep out of reach of Children

    Keep out of reach of Children

    Discontinue Use

    If irritation occurs, discontinue use

  • 130 sheet package NDC:79032-209-13

    Hand Sanitizing Wipes Retail Label

    Outer Carton Image NDC:79032-209-23

    Outer Carton

    Active Ingredient

    Ethanol 56% m/m CASE 64-17-5

    Inactive Ingredients

    Water, Glycerin, Perume, Heterotheca inuloides flower extract, Thriethanolamine

    Purpose

    The Hand sanitizing wipe cleans, disinfects, deodorizes, allows the destruction of microbes, germs, bacteria, and facilitates their total elimination. Hand sanitizing is a bactericidal, fungicidal, virucidal wipe for an effective disinection. Hand sanitizing - by its composition - ensures you a total protection of your hands with components such as glycerin and arnica

    Dosage

    Take a wipe out of the bucket. Take care to close the lid properly afterwards to avoid drying. unfold the wipe and apply to the surface to be decontaminated. the contact time for a perfect disinfection is 5 minutes. to avoid viruses, the contact time is 15 minutes.

    Usage

    Take a wipe out of the bucket. Take care to close the lid properly afterwards to avoid drying. unfold the wipe and apply to the surface to be decontaminated. the contact time for a perfect disinfection is 5 minutes. to avoid viruses, the contact time is 15 minutes.

    Warning - Flammable

    Highly Flammable liquid and vapor. Keep away from heat, hot surfaces, sparks, open flames, and all other sources of ignition. Do not smoke. Use explosion-proof electrical/ventilating/lighting equipment. Take precautionary measures against electrostatic discharge.

    Warning - Eye Irritant

    Causes severe eye irritation. Wear eye protection/face protection.

    If in eyes: rinse cautiously with water for several minutes. Remove contact lenses, if present and easily removable. Continue rinsing

    Keep out of reach of Children

    Keep out of reach of Children

    Disposal

    Dispose of contents/container in accordance with local/regional/national/international regulations.

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethanol alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79032-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.5 L  in 5 L
    Inactive Ingredients
    Ingredient NameStrength
    HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68) 0.1 L  in 5 L
    TROLAMINE (UNII: 9O3K93S3TK) 0.01 L  in 5 L
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.75 L  in 5 L
    GLYCERIN (UNII: PDC6A3C0OX) 0.045 L  in 5 L
    WATER (UNII: 059QF0KO0R) 1.4185 L  in 5 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79032-202-514 in 1 BOX07/20/2020
    1NDC:79032-202-505 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    HAND SANITIZING WIPES 
    ethanol alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79032-209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.566 
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M) 0.56 
    HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68) 0.001 
    GLYCERIN (UNII: PDC6A3C0OX) 0.011 
    WATER (UNII: 059QF0KO0R) 0.289 
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79032-209-236 in 1 BOX07/20/2020
    1NDC:79032-209-131 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2020
    HAND SANITIZER 
    ethanol alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79032-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68) 0.0002 L  in 1 L
    TROLAMINE (UNII: 9O3K93S3TK) 0.002 L  in 1 L
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.0015 L  in 1 L
    WATER (UNII: 059QF0KO0R) 0.2837 L  in 1 L
    GLYCERIN (UNII: PDC6A3C0OX) 0.009 L  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79032-213-1112 in 1 BOX07/20/2020
    1NDC:79032-213-101 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2020
    Labeler - Actalys (260814505)
    Establishment
    NameAddressID/FEIBusiness Operations
    Actalys260814505api manufacture(79032-202, 79032-213, 79032-209)
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