HAND SANITIZERPORTCALL- alcohol solution

Hand sanitizerportcall by

Drug Labeling and Warnings

Hand sanitizerportcall 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 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) (70%) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol
3. Sterile distilled water.

Active Ingredient(s)

Alcohol 70%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire and flame

Do not use

• Do not use in or near eyes.

WHEN USING

When using this product do not use in or ner eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts. 
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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, citrus aurantium dulcis peel oil, tocopheryl acetate, maltodextrin, parfum

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZERPORTCALL 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76650-119
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
maltodextrin (UNII: 7CVR7L4A2D)
ORANGE PEEL (UNII: TI9T76XD44)
ALOE (UNII: V5VD430YW9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76650-119-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - Genesis Salon Products LLC (079511065)

Registrant - Cospro Development Corp (785638821)

Establishment
Name	Address	ID/FEI	Business Operations
Cospro Development Corp		785638821	manufacture(76650-119) , label(76650-119) , pack(76650-119)