HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ginesis Natural Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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DRUG FACTS

Active ingredient

Ethyl Alcohol 80%

Purpose

Antiseptic

Uses

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 fire or flames.

Do not use

• on children less than 2 months of age
• on open skin wounds

When using this product avoid contact with eyes, ears and mouth. In case of contact flush eyes with water.

Stop use and ask doctor if redness or irritation develop. 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 15-30° C (59-86°F)
• Avoid freezing and excessive heat above 40° (104°F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

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DIST. BY CJH
2501 COUNTY RD 8
WATERLOO, AL 35677

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

GINESIS

Alcohol Antiseptic 80%
Topical Solution

Hand Sanitizer
Non-Sterile Solution

2 FL OZ. (59 ML)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79703-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
glycerin (UNII: PDC6A3C0OX)
hydrogen peroxide (UNII: BBX060AN9V)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79703-080-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2020
2	NDC: 79703-080-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2020
3	NDC: 79703-080-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2020
4	NDC: 79703-080-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2020
5	NDC: 79703-080-10	3784 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2020

Labeler - Ginesis Natural Products (621843130)

Establishment
Name	Address	ID/FEI	Business Operations
Ginesis Natural Products		621843130	MANUFACTURE(79703-080)