Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

on 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 right away.

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 right away.

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

Water (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone

Package Label - Principal Display Panel

1 Gal 3780 mL NDC: 74751-008-01

DIRE 70% GEL HAND SANITIZER - W
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74751-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70.6646 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
MYRISTYL LACTATE (UNII: 1D822OC34X)	0.3895 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.0012 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.5177 mL in 100 mL
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)	0.0924 mL in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	0.2087 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.1284 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.2805 mL in 100 mL
WATER (UNII: 059QF0KO0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)	0.0215 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74751-008-01	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2020
2	NDC:74751-008-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2020
3	NDC:74751-008-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2020
4	NDC:74751-008-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/01/2020

Labeler - Applichem, Inc (039829528)