GERMIFREE ANTIMICROBIAL HAND GEL- ethyl alcohol gel

GermiFree Antimicrobial Hand Gel by

Drug Labeling and Warnings

GermiFree Antimicrobial Hand Gel by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 60% w/w

Purpose

Antimicrobial

Use

hand sanitizer to help reduce microbes on the skin

Warnings

Flammable. Keep away from fire or flame

For external use only

When using this product, do not use in or near the eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours and continues

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

Directions

put enough gel in your palm to cover hands and rub hands together rapidly until dry

children under 6 years of age should be supervised when using this product

Other information

store below 110°F (43°C)

may discolor certain fabrics or surfaces

Inactive ingredients

carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

SPL UNCLASSIFIED SECTION

Kill Germs up to 99.99% of most common germs that may cause illness

Distributed by:

Acme United Corporation

55 Walls Drive

Fairfield, CT 06824

1-800-835-2263

Made in Egypt

Packaging

INGREDIENTS AND APPEARANCE

GERMIFREE ANTIMICROBIAL HAND GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0400(NDC:28691-6000)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	67.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON (UNII: Z4152N8IUI)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0400-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020
2	NDC: 0924-0400-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020
3	NDC: 0924-0400-03	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020
4	NDC: 0924-0400-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020
5	NDC: 0924-0400-05	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020
6	NDC: 0924-0400-06	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/11/2020

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-0400) , repack(0924-0400)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-0400) , repack(0924-0400)