HAND SANITIZER- ethyl alcohol 70% gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Premium Printing Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70%

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 heat or flame.

Do not use

In children less than 2 months of age. On open skin wounds.

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 immediately.

­­­­­­­­­­­­­­­­­­­­­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 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Carbopol, Glycerin, Triethanolamine

Gel Hand Sanitizer

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol 70% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78635-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	175 mL  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
TRIETHANOLAMINE ISOSTEARATE (UNII: T8OTU5ECY5)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78635-100-08	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 78635-100-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 78635-100-04	4000 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 - Premium Printing Inc. (035632750)

Registrant - Premium Printing Inc. (035632750)