Active Ingredient(s)

Ethyl Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

When using this product avoid contact with face, eyes, and broken skin. If eyes contact occurs, flush thoroughly with water and seek medical advice.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hand thoroughly with product and rub into skin until dry.
Children under 6 years of age should be supervised by an adult when using this product.

Inactive ingredients

aqua (water, eau), propylene glycol, glycerin, carbomer, aminomethyl propanol, isopropyl myristate, t-butyl alcohol

Package Label - Principal Display Panel

dial pdp 221 mL NDC: 61531-389-01

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61531-389
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ)	0.5 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61531-389-01	221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - PakLab (790530976)

Registrant - PakLab (790530976)

Name	Address	ID/FEI	Business Operations
Establishment
PakLab		790530976	manufacture(61531-389) , label(61531-389) , pack(61531-389)