HAND SANITIZER- alcohol gel 
Tu Negocio En Minutos SA de CV

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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Tahor 1 Litter Hand Sanitizer

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. TRIETHANOLAMINE BENZOATE (0.125% v/v).
  4. Carbomer 940 0.5%
  5. 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 70%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To decrease bacteria on the skin that could cause disease, Recommended for repeated use

Warnings

For external use only: hands Do not drink Flammable. Keep away from heat and flame

Do not use

Keep out of eyes in case of contact with eyes, flush thoroughly with water, Avoid contact with broken skin,

Do not inhale or ingest.

Skin irritation develops.

If swallowed, get medical help or contact a Poison Control Center Right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Other information

Do not store above105oF, may discolor some fabrics, Harmful to wood finishes and plastics.

Inactive ingredients

Purified Water, Glycerin, Triethanolamine, Carbomer.

Package Label - Principal Display Panel

1.000 mL1000 mL NDC: 79219-001-02

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79219-001
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
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79219-001-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Tu Negocio En Minutos SA de CV (951578971)
Registrant - Tu Negocio En Minutos SA de CV (951578971)

Revised: 7/2020
Document Id: ab0adc62-e3c9-9eeb-e053-2a95a90a0eeb
Set id: aaf9d52c-b35d-bc11-e053-2a95a90aec06
Version: 2
Effective Time: 20200722
 
Tu Negocio En Minutos SA de CV