Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)
Aero Healthcare, LLC.
TOPICAL
OTC DRUG
Topical Antiseptic Topical Anesthetic for help in control of superficial bleeding and temporary relief of pain of: - minor cuts and scrapes - minor burns - in or near mucous membranes - on serious burns - on raw surfaces - on deep puncture wounds - for a prolonged period of time - on blistered areas - on a large portion of the body - on animal bites - redness, swelling, or irritation occurs - infection occurs - condition persists or worsens - symptoms persist for more than 7 days
OTC monograph not final
AEROWOUND BLOOD CLOTTING FIRST AID- BENZETHONIUM CHLORIDE AND LIDOCAINE AEROSOL, SPRAY AERO HEALTHCARE, 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._ ---------- AEROWOUND BLOOD CLOTTING SPRAY ACTIVE INGREDIENTS Benzethonium Chloride 0.2% w/w Lidocaine 4% w/w PURPOS E Topical Antiseptic Topical Anesthetic US ES for help in control of superficial bleeding and temporary relief of pain of: minor cuts and scrapes minor burns WARNINGS FOR EXTERNAL USE ONLY FLAMMABLE keep away from flame contents under pressure do not puncture or incinerate do not expose to temperatures above 120°F DO NOT USE in or near mucous membranes on serious burns on raw surfaces on deep puncture wounds for a prolonged period of time on blistered areas on a large portion of the body on animal bites STOP USE AND ASK DOCTOR IF redness, swelling, or irritation occurs infection occurs condition persists or worsens symptoms persist for more than 7 days KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS shake can well before using hold 6-8 inches from moist injured area spray until area is covered for adult use only not intended for use on children scab-like cover will gradually disappear as healing takes place or may be removed with soap and water INACTIVE INGREDIENTS Isobutane, Isopropyl Myristate, Karaya, n-Butane, Propane, Silica, Silicone, Sorbitan Monooleate, Talc, Tragacanth PRINCIPAL DISPLAY AEROWOUND BLOOD CLOTTING FIRST AID benzethonium chloride and lidocaine aerosol, spray PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:5530 5-114(NDC:529 8 2-10 6 ) ROUTE OF ADMINISTRATION TOPICAL Aero Healthcare, LLC. ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7) LIDOCAINE 756 .5 mg in 8 5 g BENZETH read_full_document