HAND SANITIZER- ethyl alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Golden Applexx Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Ethyl Alcohol 62%

Purpose:

Antiseptic

Uses:

hand sanitizer to decrease bacteria on the skin

recommended for repeated use

for use when soap and water are not available

WARNING:

For External Use Only

Do not apply in or around eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and ask a doctor if irritation and redness develop and last for more than 72 hours. Get immediate medical help if swallowed.
Flammable, keep away from fire or flame.

Keep Out of Reach of Children

Directions:

wet hands thoroughly with product and allow to dry without wiping

supervise children under 6 years of age when using this product to avoid swallowing

Inactive Ingredients:

Water, Glycerin, Essential Oils

SPL UNCLASSIFIED SECTION

Distributed by: Golden Applexx STOPNGO Line Industry, CA 91789

MADE IN USA

Packaging

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73742-101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73742-101-59	1 in 1 CARTON	03/23/2020
1		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/23/2020

Labeler - Golden Applexx Co., Inc. (152634010)

Establishment
Name	Address	ID/FEI	Business Operations
Golden Applexx Co., Inc.		152634010	manufacture(73742-101)