GERMISEPT ANTIBACTERIAL ALCOHOL HAND SANITIZER- alcohol gel 
Alpha Hygiene LLC

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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Germisept Anti-Bacterial Alcohol Hand sanitizer Gel

Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

Warnings

When using this product

  • keep out of eyes.
  • In case of contact with eyes, flush throughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Aqua (Water), Glycerin, Acrylates/c10-30 alkyl acrylate crosspolymer, Aminomethyl propanol, Fragrance (Perfume).

Package Labeling:1000ml

Label

Package Labeling:3800ml

Bottle2

GERMISEPT ANTIBACTERIAL ALCOHOL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80862-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80862-000-011000 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2020
2NDC:80862-000-023800 mL in 1 CAN; Type 0: Not a Combination Product11/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/01/2020
Labeler - Alpha Hygiene LLC (063055824)

Revised: 10/2020
Document Id: b2a7bafc-4c0f-e927-e053-2a95a90a9234
Set id: b2a7bafc-4c0e-e927-e053-2a95a90a9234
Version: 1
Effective Time: 20201027
 
Alpha Hygiene LLC