GERM FREE PLUS ANTIBACTERIAL HAND SANITIZER- alcohol gel

Germ Free Plus Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Germ Free Plus Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Rompac, Inc., Distribuidora Química Textil S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

STORAGE AND HANDLING

Do not store above 105°F

PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

Rompac

GermFree +

70% ALCOHOL
Antibacterial Hand Sanitizer
GEL

1 Gallon (3.785 liters)

INGREDIENTS AND APPEARANCE

GERM FREE PLUS ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79357-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Triethanolamine Lactate (UNII: 064C51N81O)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79357-001-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	07/08/2020

Labeler - Rompac, Inc. (066717747)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Química Textil S.A. de C.V.		811522390	MANUFACTURE(79357-001)