HAND SANITIZER- ethanol gel 
Fifth Generation, Inc.

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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Hand sanitizer

Ethanol 80% v/v

Antiseptic

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

For external use only. Flammable. Keep away from heat or flame

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

Other Information:

Store between 15-30c (59-86F)

Avoid freezing and excessive heat above 40 C (104F)

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer

200 mL 73982-000-01

100 mL 73982-000-00

375 mL 73982-000-02

3785 mL 73982-000-03

11356mL 73982-000-04

18927 mL 73982-000-05

208197 mL 73982-000-06

Package Front LabelPackage Back Label

HAND SANITIZER 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73982-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73982-000-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
2NDC:73982-000-00100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
3NDC:73982-000-02375 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
4NDC:73982-000-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
5NDC:73982-000-0411356 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
6NDC:73982-000-0518927 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
7NDC:73982-000-06208197 mL in 1 DRUM; Type 0: Not a Combination Product03/27/2020
8NDC:73982-000-0750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/27/2020
Labeler - Fifth Generation, Inc. (961445723)
Establishment
NameAddressID/FEIBusiness Operations
Fifth Generation, Inc.961445723manufacture(73982-000)

Revised: 8/2020
Document Id: ac4cacbd-657d-d0de-e053-2995a90aea62
Set id: a1daad10-f217-2254-e053-2995a90abaa9
Version: 3
Effective Time: 20200807
 
Fifth Generation, Inc.