Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
FiteBac SkinCare, LLC
TOPICAL
OTC DRUG
Antimicrobial - For hand sanitizing to decrease bacteria on the skin
OTC monograph not final
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._ ---------- 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 Soma hati kamili