HANDSANITIZERAMERICANMALE- alcohol solution

HandSanitizerAmericanMale by

Drug Labeling and Warnings

HandSanitizerAmericanMale by is a Otc medication manufactured, distributed, or labeled by Genesis Salon Products LLC, Cospro Development Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand rub 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)
2. Glycerol.
3. Hydrogen peroxide.
4. Sterile distilled water.

Active Ingredient(s)

Ethyl Alcohol 70%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin

Warnings

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

Do not use

• in or around eyes

WHEN USING

When using this product do not use in or near eyes. If contact occurs, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts. 

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Put enough product in your palm to cover hands and rub together briskly until dry. 
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110F (43C)
• May discolor certain fabrics or surfaces

Inactive ingredients

deionized water, glycerin, polysorbate 20, aloe barbadensis leaf juice, orange peel oil, tocopheryl acetate, maltodextrin, parfum

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HANDSANITIZERAMERICANMALE 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76650-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
ORANGE PEEL (UNII: TI9T76XD44)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76650-121-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/09/2020

Labeler - Genesis Salon Products LLC (079511065)

Registrant - Cospro Development Corp (785638821)

Establishment
Name	Address	ID/FEI	Business Operations
Cospro Development Corp		785638821	manufacture(76650-121) , pack(76650-121) , label(76650-121)