HAND SANITIZER- ethanol alcohol gel 
HAND SANITIZING WIPES- ethanol alcohol cloth 
Actalys

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.

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Hand Sanitizer

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.

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)

Revised: 7/2020
Document Id: a9f38e2b-d800-67da-e053-2a95a90a7caa
Set id: a9f38e2b-d7ff-67da-e053-2a95a90a7caa
Version: 1
Effective Time: 20200708
 
Actalys