ANTIBACTERIAL HAND SANITIZER- alcohol spray
National Design LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antibacterial hand sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 68%

Purpose

Antiseptic

Uses

For hand sanitizing

Warnings

For external use only hands.

Flammable. Keep away from heat or flame.

When using this product

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

Keep out of reach of children

Other information:

store at 20°C (68° to 77° F). may discolor fabrics.

Ingreidients:

Glycerin, propylene glycol, triethanolamine, carbomer, fragrance, disodium edta, tocopheryl acetate, deionized water.

Package Labeling:

Bottle Label

ANTIBACTERIAL HAND SANITIZER
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80575-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.68 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80575-000-01	10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/01/2020

Labeler - National Design LLC. (360763320)