HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L3VEL3 LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Hand Sanitizer

DESCRIPTION:

LEVEL3 Hand Sanitizer provides powerful protection against germs, bacteria, and infections. Specially formulated for maximum protection, the non-sticky formula dries up quickly, leaving your hands feeling refreshed and sanitized.

Directions

Pour enough product in your palm to cover hands and rub your hands together quickly until dry.

Warnings

For external use only. Keep away from fire or flame, it is flammable. Keep out of the reach of children. Get medical attention if swallowed. Do not leave it under sunlight and higher than 104ºF (40ºC ). Avoid contact with the eyes. In case of contact with eyes, rinse with plenty of water.

Warnings:

Keep out of the reach of children. Get medical attention if swallowed.

Ingredients:

Alcohol Denat, Isopropyl Alcohol.

Ingredients:

Aqua, Glycerin, Polysorbate 20, Carbomer, Triethanolamine.

Package Label - Principal Display Panel

Aqua 50 mL Label NDC: 80848-001-01

Aqua 250 mL Label NDC: 80848-001-02

Ice 50 mL Label NDC: 80848-001-03

Ice 250 mL Label NDC: 80848-001-04

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80848-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	64 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	10 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)	1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)	0.6 mL  in 100 mL
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)	0.4 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80848-001-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2020
2	NDC: 80848-001-02	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2020
3	NDC: 80848-001-03	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2020
4	NDC: 80848-001-04	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/12/2020

Labeler - L3VEL3 LLC (128877852)