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 60% 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)

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

untitled

GERMIFREE ANTIMICROBIAL HAND GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 28691-0060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON (UNII: Z4152N8IUI)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 28691-0060-160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/202004/04/2020
2NDC: 28691-0060-2100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/202004/04/2020
3NDC: 28691-0060-3200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/202004/04/2020
4NDC: 28691-0060-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/202004/04/2020
5NDC: 28691-0060-5750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/202004/04/2020
6NDC: 28691-0060-61000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/202004/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/14/202004/04/2020
Labeler - Pharmaplast SAE (557735337)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaplast SAE557735337manufacture(28691-0060)

Revised: 4/2020
 
Pharmaplast SAE