HAND SANITIZER- ethanol alcohol solution 
Alquim Especialidades Químicas, S.A. de C.V.

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

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)

Ethanol Alcohol 72% V/V purpose antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Health care personnel hand rub to help reduce bateria that potentially can cause disease.

Warnings

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

Do not use

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 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.

Directions

Other information

Inactive ingredients

alquimWater, Glycerin UPS, Carbomer, Triethanolamine, DMDM Hydantion & Perfume

Package Label - Principal Display Panel

4125 mL NDC: 78690-001-01

250 ml NDC: 78690-001-02

3785 ml NDC: 78690-001-03

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HAND SANITIZER 
ethanol alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78690-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 26.24 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.05 mL  in 100 mL
DMDM HYDANTOIN (UNII: BYR0546TOW) 0.01 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78690-001-01125 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
2NDC:78690-001-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
3NDC:78690-001-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/24/2020
Labeler - Alquim Especialidades Químicas, S.A. de C.V. (812821728)
Registrant - Alquim Especialidades Químicas, S.A. de C.V. (812821728)
Establishment
NameAddressID/FEIBusiness Operations
Alquim Especialidades Químicas, S.A. de C.V.812821728manufacture(78690-001)

Revised: 6/2020
Document Id: a8dc8982-fc3f-645f-e053-2a95a90a7e86
Set id: a8dc8b44-2f26-04a8-e053-2995a90a6ae8
Version: 1
Effective Time: 20200624
 
Alquim Especialidades Químicas, S.A. de C.V.