FITEBAC HAND SANITIZER- benzalkonium chloride gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
FiteBac SkinCare, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antimicrobial - For hand sanitizing to decrease bacteria on the skin
Authorization status:
OTC monograph not final
Authorization number:
13136-002-01, 13136-002-02

FITEBAC HAND SANITIZER- benzalkonium chloride gel

FiteBac SkinCare, 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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FiteBac Hand Sanitizer

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1%

Purpos e

Antimicrobial

Us es

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

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

Distributed by FiteBac SkinCare, LLC, Marietta, Georgia 30064

PRINCIPAL DISPLAY PANEL

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FITEBAC HAND SANITIZER

benzalkonium chloride gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:13136 -0 0 2

FiteBac SkinCare, LLC

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

DIMETHICO NE CRO SSPO LYMER ( 4 50 0 0 0 MPA.S AT 12 % IN CYCLO PENTASILO XANE) (UNII: UF76 20 L1W6 )

PPG-3 BENZYL ETHER ETHYLHEXANO ATE (UNII: 3N70 3GY9 9 W)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:13136 -0 0 2-

8 5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 1/20 19

2

NDC:13136 -0 0 2-

10 0 0 g in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 2/0 1/20 19

Labeler -

FiteBac SkinCare, LLC (969593313)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dhaliwal Labo rato ries LLC

0 16 75420 1

ma nufa c ture (13136 -0 0 2)

Revised: 3/2019

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