GEL HAND SANITIZER- alcohol gel

Gel Hand Sanitizer by

Drug Labeling and Warnings

Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by 5 Peaks Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To help reduce bacteria on skin.

Warnings

For external use only. Flammable, keep away from source of heat & fire.

WHEN USING

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

STOP USE

Stop use & ask doctor if irritation occurs or redness develops & persists.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

Directions

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

Inactive ingredients

Water (Aqua, Eau), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

Package Label - Principal Display Panel

100 mL NDC: 80242-100-01

250 mL NDC: 80242-100-02

500 mL NDC: 80242-100-03

1 L NDC: 80242-100-04

3.785 L NDC: 80242-100-05

208 L NDC: 80242-100-06

1000 L NDC: 80242-100-07

iUnderstand Product Label

250 mL NDC: 80242-100-02

500 mL NDC: 80242-100-03

1 L NDC: 80242-100-04

INGREDIENTS AND APPEARANCE

GEL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80242-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SQUALANE (UNII: GW89575KF9)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80242-100-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2020
2	NDC: 80242-100-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
3	NDC: 80242-100-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
4	NDC: 80242-100-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
5	NDC: 80242-100-05	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
6	NDC: 80242-100-06	208000 mL in 1 DRUM; Type 0: Not a Combination Product	09/01/2020
7	NDC: 80242-100-07	1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - 5 Peaks Products, LLC (117631506)

Registrant - 5 Peaks Products, LLC (117631506)