HAND SANITIZER- alcohol solution 
Solquim SA DE CV

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.

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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 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

  • 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

DRUM 1000000 ML

DRUM 20000 ML

BOTTLE 4000 ML

BOTTLE 120 ML

BOTTLE 60MLBOTTLE 500 MLDRUM 50 L

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
Labeler - Solquim SA DE CV (821362605)
Establishment
NameAddressID/FEIBusiness Operations
Solquim S.A. de C.V.821362605manufacture(74161-175)

Revised: 5/2020
 
Solquim SA DE CV