GERM SHARK PX4 HAND SANITIZER- alcohol liquid

Germ Shark PX4 Hand Sanitizer by

Drug Labeling and Warnings

Germ Shark PX4 Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Germ Shark LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient(s)

Alcohol 80% v/v

Purpose

Antiseptic

Inactive Ingredients

Purified water USP 18.425%, Glycerin (glycerol) 1.45%, Hydrogen peroxide 0.125%

Use(s)

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

• on children less than 2 months of age- supervise use by children
• on open skin wounds
• do NOT drink - not for internal consumption

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.

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

• Avoid freezing and excessive heat above 40C (104F)
• Store between 15-30C (59-86F)

Package Labeling:

INGREDIENTS AND APPEARANCE

GERM SHARK PX4 HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75158-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75158-002-00	3790 mL in 1 JUG; Type 0: Not a Combination Product	06/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/03/2020

Labeler - Germ Shark LLC (117480758)