GERM FREE PLUS ANTIBACTERIAL HAND SANITIZER- alcohol gel 
Rompac, 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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Germ Free + Antibacterial Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antibacterial

Inactive ingredients

Water, Carbomer, Triethanolamine, Glycerin

Uses

For hand washing to reduce the bacteria on the skin, recommended for repeated use.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Warnings

For external use only: hands. Flammable, keep away from fire or flame. When using this product, keep out of eyes. In case of contact with eyes rinse with water. Stop use and ask a doctor if irritation and redness develop and persist.

Keep out of reach of children.

If swallowed, get medical help immediately.

Do not store above 105°F

PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

Rompac

Germ•Free +

70% ALCOHOL
Antibacterial Hand Sanitizer
GEL

1 Gallon (3.785 liters)

PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label
GERM FREE PLUS ANTIBACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79357-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Triethanolamine Lactate (UNII: 064C51N81O)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79357-001-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A07/08/2020
Labeler - Rompac, Inc. (066717747)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Química Textil S.A. de C.V.811522390MANUFACTURE(79357-001)

Revised: 7/2020
Document Id: dfb23948-db4e-411a-a96f-3fed43a39b26
Set id: 4e9fa74f-aae0-4497-b3f5-36a853e1f81b
Version: 1
Effective Time: 20200715
 
Rompac, Inc.