AME HAND SANITIZER- hand sanitizer liquid 
DR.AMERICO GROUP JOINT STOCK COMPANY

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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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. 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

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

glycerin, purified water USP

378525010050001000500

AME HAND SANITIZER 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80870-801
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80870-801-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
2NDC:80870-801-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
3NDC:80870-801-053785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
4NDC:80870-801-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
5NDC:80870-801-065000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
6NDC:80870-801-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/22/2020
Labeler - DR.AMERICO GROUP JOINT STOCK COMPANY (555835686)
Establishment
NameAddressID/FEIBusiness Operations
DR.AMERICO GROUP JOINT STOCK COMPANY555835686relabel(80870-801)

Revised: 12/2020
Document Id: b5b624ca-0b3f-791f-e053-2a95a90a9a50
Set id: b2322b28-42aa-18c3-e053-2a95a90a2256
Version: 2
Effective Time: 20201205
 
DR.AMERICO GROUP JOINT STOCK COMPANY