Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
Benzalkonium Chloride 0.1%, Benzocaine 5.0%
Safetec of America, Inc.
TOPICAL
OTC DRUG
First Aid Antiseptic Topical Pain Relief First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns
OTC monograph not final
ANTISEPTIC- BENZALKONIUM CHLORIDE, BENZOCAINE SPRAY SAFETEC OF AMERICA, INC. ---------- 61010-5300, CUT AND SCRAPE ANTISEPTIC DRUG FACTS ACTIVE INGREDIENTS Benzalkonium Chloride 0.1% Benzocaine 5.0% PURPOSE First Aid Antiseptic Topical Pain Relief USES First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE KEEP AWAY FROM FIRE OR FLAME. DO NOT USE near eyes or mucous membranes on deep or puncture wounds, animal bites, or serious burns over large areas of the body more than one week unless directed by a doctor KEEP OUT OF REACH OF CHILDREN.If swallowed get medical help or contact a Poison Control Center right away. STOP USE AND ASK DOCTOR IFcondition persists or gets worse DIRECTIONS clean affected and spray 1 to 3 times daily may be covered with a sterile bandage children under 2 ask a doctor. INACTIVE INGREDIENTS isopropyl alcohol, purified water PRINCIPAL DISPLAY PANEL – BOTTLE LABEL NDC 61010-5300-0 Safetec Cut & Scrape Antiseptic Spray For Temporary Pain Relief and to Help Prevent Infection in Minor Cuts, Scrapes and Abrasions. 2 fl. oz. (59.1ml) Reorder no. 53000 ANTISEPTIC benzalkonium chloride, benzocaine spray PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:61010-5300 Safetec of America, Inc. 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 mg in 1 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZ OCAINE 50 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:61010- 5300-2 90 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/15/2012 2 NDC:61010- 5300-0 60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/15/2012 MARKETING INFORMATION MARKETING CATEGORY APPLI Lire le document complet