HAND SANITIZER- alcohol liquid 
Gervasi 1700 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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Hand sanitizer

Alcohol 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 533mL
Hand Sanitizer 3785mL
Hand Sanitizer 946mL

Hand Sanitizer 946mL ComboHand Sanitizer 3785mL FrontHand Sanitizer 3785mL Back533mL Front Label533mL Back LabelLabel

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74123-001
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
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74123-001-01533 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74123-001-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:74123-001-03946 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Gervasi 1700 LLC (010606034)
Establishment
NameAddressID/FEIBusiness Operations
Gervasi 1700 LLC010606034manufacture(74123-001)

Revised: 4/2020
Document Id: a3cd5297-cf9f-963d-e053-2995a90a342f
Set id: a1edccf7-ff0d-5c19-e053-2a95a90a234e
Version: 2
Effective Time: 20200421
 
Gervasi 1700 LLC