Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses:

For Hand Sanitizing

Warnings:

For external use only-hands.

Flammable. Keep away from heat and flame.

When using this product

Keep out of eyes. In case of contact with eyes, flush thoroughly with water
Avoid contact with broken skin.
Do not inhale or ingest.

Stop use and ask a doctor

If skin irritation develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Wet hands thoroughly with product and allow to dry without wiping.
For children under 6 age use only under adult supervision.
Not recommended for infants

Other Information:

Do not store above 105°F.
May discolor some fabrics.
Harmful to wood finishes and plastics

Inactive Ingredients

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Package Labeling:30ml

30 ml 30 ml

Package Labeling:53ml

Bottle53ml

Package Labeling:60ml

Bottle60ml

Package Labeling:15ml

Bottle15mlA Bottle15mlB

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80524-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80524-000-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020
2	NDC:80524-000-53	53 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020
3	NDC:80524-000-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020
4	NDC:80524-000-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	09/18/2020

Labeler - Tempo Industries, Inc. (883232993)

Hand Sanitizer