Country: United States
Language: English
Source: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Demoulas Super Markets, Inc
TOPICAL
OTC DRUG
Antibacterial for handwashing to decrease bacteria on the skin - irritation or redness develops - condition persists for more than 72 hours
OTC monograph not final
HAND WASH- BENZALKONIUM CHLORIDE LIQUID DEMOULAS SUPER MARKETS, INC _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._ ---------- AMBER ANTIBACTERIAL HAND SOAP 403.002/403AC ACTIVE INGREDIENT Benzalkonium chloride 0.13% PURPOSE Antibacterial USE for handwashing to decrease bacteria on the skin WARNINGS FOR EXTERNAL USE ONLY: HANDS ONLY WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR IF irritation or redness develops 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 wet hands apply palmful to hands scrub thoroughly rinse thoroughly INACTIVE INGREDIENTS water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG- 150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 4, yellow 5 ADVERSE REACTIONS DISTRIBUTED BY DEMOLAS SUPER MARKETS, INC. 875 EAST STREET, TEWKSBURY, MA 01876 PRNCIPAL DISPLAY PANEL "MORE FOR YOUR DOLLAR" MARKET BASKET ANTIBACTERIAL LIQUID HAND SOAP 7.5 FL OZ (221 mL) HAND WASH benzalkonium chloride liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:53942-403 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZ ALKONIUM CHLORIDE 1.3 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) SODIUM CHLORIDE (UNII: 451W47IQ8X) MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T) GLYCERIN (UNII: PDC6A3C0OX) DISTEARETH-75 ISOPHORON Read the complete document