FITEBAC HAND SANITIZER- benzalkonium chloride gel

FiteBac Hand Sanitizer by

Drug Labeling and Warnings

FiteBac Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by FiteBac SkinCare, LLC, Dhaliwal Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

• For hand sanitizing to decrease bacteria on the skin

Warnings

For external use only

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if 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

• Use only a small, pea-sized amount as needed, which is enough to cover both your hands.
• Rub thoroughly over all surfaces of both hands

STORAGE AND HANDLING

• Not intended to provide ongoing protection against new germ exposure

Inactive ingredients

Cyclopentasiloxane, Dimethicone Crosspolymer, PPG-3 Benzyl Ether Ethylhexanoate

Questions, comments, side effects or reordering

770-218-6221

SPL UNCLASSIFIED SECTION

Distributed by FiteBac SkinCare, LLC, Marietta, Georgia 30064

PRINCIPAL DISPLAY PANEL

Tube Display

INGREDIENTS AND APPEARANCE

FITEBAC HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13136-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PPG-3 BENZYL ETHER ETHYLHEXANOATE (UNII: 3N703GY99W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13136-002-01	85 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2019
2	NDC: 13136-002-02	1000 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2019

Labeler - FiteBac SkinCare, LLC (969593313)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Laboratories LLC		016754201	manufacture(13136-002)