FITEBAC HAND SANITIZER- benzalkonium chloride gel

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

제공처:

FiteBac SkinCare, LLC

관리 경로:

TOPICAL

처방전 유형:

OTC DRUG

치료 징후:

Antimicrobial - For hand sanitizing to decrease bacteria on the skin

승인 상태:

OTC monograph not final

제품 특성 요약

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
Tube Display
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-
0 1
8 5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 2/0 1/20 19
2
NDC:131