Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
MRJ'S CROWN INDUSTRIES PRIVATE LIMITED
TOPICAL
OTC DRUG
Antibacterial For washing to decrease bacteria on the skin
OTC monograph not final
AMERFRESH ANTIBACTERIAL UNWRAPPED- BENZALKONIUM CHLORIDE SOAP MRJ'S CROWN INDUSTRIES PRIVATE LIMITED _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._ ---------- ACTIVE INGREDIENT Benzalkonium Chloride 0.1% PURPOSE Antibacterial USE For washing to decrease bacteria on the skin WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT avoid contact with eyes .in case of eyes contact ,flush with water STOP USE AND DOCTOR ASK IF irritation and redness develops KEEP OUT OF REACH OF CHILDREN if swallowed ,get medical help or contact a Poison control center right away . DIRECTIONS • Wet bar with water • Lather vigorously and wash skin • Rinse and dry thoroughly INACTIVE INGREDIENTS • Sodium Palmitate • Palm Kernelate • Fragrance • Aqua • Sodium Chloride • Glycerine • Titanium Di Oxide • Tetra Sodium EDTA PRODUCT LABEL AMERFRESH ANTIBACTERIAL UNWRAPPED benzalkonium chloride soap PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:80865-002 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZ ALKONIUM CHLORIDE 0.068 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH SODIUM PALMITATE (UNII: JQ43KP6296) PALM KERNEL OIL (UNII: B0S90M0233) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) EDETATE SODIUM (UNII: MP1J8420LU) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:80865-002- 01 200 in 1 CARTON 11/19/2020 1 10 in 1 PACKAGE; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING APPLICATION NUMBER OR MONOGRAPH MARKETING START MARKETING END MRJ'S CROWN INDUSTRIES PRIVATE LIMITED CATEGORY CITATION DATE DATE OTC monograph not final part333A 11/19/2020 LABELER - MRJ'S CROWN INDUST Läs hela dokumentet