FITEBAC SKINCARE GERMICIDAL HAND SOFTENING- benzalkonium chloride gel

fiteBac SkinCare by

Drug Labeling and Warnings

fiteBac SkinCare by is a Otc medication manufactured, distributed, or labeled by fiteBac SkinCare, LLC, CBI Laboratories, Inc., AmeriPac, Inc.. 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
• Recommended for repeated use

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

Other Information

• Not intended to provide ongoing protection against new germ exposure

Inactive ingredients

Cyclopentasiloxane, Dimethacone Crosspolymer, PPG-3 Benzyl Ether Ethylhexanoate, Octadecyldimethyl Trimethoxysilylpropyl Ammonium Chloride

Questions, comments, side effects or reordering

1-855-222-1640.

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Distributed by fiteBac SkinCare, LLC, Marietta, Georgia 30064

PRINCIPAL DISPLAY PANEL - 85.05 g Tube Label

GERMICIDAL
HAND SOFTENING GEL
Benzalkonium Chloride

fiteBac™
SkinCare
"A little bit goes a long way"

• Kills Bacteria
• Non-Greasy
• Petroleum Free
• Hydrophobic
• Alcohol Free
• Fragrance Free
• Water Free
• Cost-Effective

Unique patent pending formulation kills
bacteria while helping to strengthen
the skin's moisture barrier. Helps keep
skin velvety soft, even after frequent
handwashing or exposure to gloves or
other harsh environments.

NET WT 3.0 OZ (85.05g)

www.fiteBac.com

INGREDIENTS AND APPEARANCE

FITEBAC SKINCARE   GERMICIDAL HAND SOFTENING
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13136-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.029 mL  in 29.57 mL

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13136-001-01	29.57 mL in 1 TUBE
2	NDC: 13136-001-02	88.72 mL in 1 TUBE
3	NDC: 13136-001-03	236.59 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/15/2011

Labeler - fiteBac SkinCare, LLC (969593313)

Establishment
Name	Address	ID/FEI	Business Operations
CBI Laboratories, Inc.		623704368	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
AmeriPac, Inc.		196515639	PACK