GermiFree Antimicrobial Hand Gel

GermiFree Antimicrobial Hand Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

GERMIFREE ANTIMICROBIAL HAND GEL- ethyl alcohol gel 
Pharmaplast SAE

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GermiFree Antimicrobial Hand Gel

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

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)

Kills more than 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

GERMIFREE ANTIMICROBIAL HAND GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28691-0070
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
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: 28691-0070-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2020	04/04/2020
2	NDC: 28691-0070-2	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2020	04/04/2020
3	NDC: 28691-0070-3	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2020	04/04/2020
4	NDC: 28691-0070-4	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2020	04/04/2020
5	NDC: 28691-0070-5	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2020	04/04/2020
6	NDC: 28691-0070-6	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2020	04/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/23/2020	04/04/2020

Labeler - Pharmaplast SAE (557735337)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaplast SAE		557735337	manufacture(28691-0070)

Revised: 4/2020

Document Id: 2c1712bf-f2c3-4423-9f42-4d34f7ca276b

34390-5

Set id: 1a79a68d-3384-471f-b564-abd79092e666

Version: 2

Effective Time: 20200410