Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
DENTAL
OTC DRUG
Oral Anesthetic For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures. - for more than 7 days unless directed by a dentist or doctor. - If sore mouth symptoms do not improve in 7 days - irritation, pain, or redness persists or worsens - if swelling, rash or fever develops, see your dentist or doctor promptly. If the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray, or blue coloured skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
OTC monograph not final
COMFORTCAINE TOPICAL ANESTHETIC- BENZOCAINE GEL MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS 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._ ---------- COMFORTCAINE MINT ACTIVE INGREDIENTS (IN EACH GRAM) Benzocaine 200 mg PURPOS E Oral Anesthetic US ES For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures. WARNINGS ALLERGY ALERT: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics. DO NOT USE for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens if swelling, rash or fever develops, see your dentist or doctor promptly. WHEN USING THIS PRODUCT Avoid contact with eyes. If contact occurs, flush with water. STOP USE AND CONSULT A HEALTH CARE PRACTITIONER If the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray, or blue coloured skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. DO NOT EXCEED RECOMMENDED DOSAGE. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately. IF PREGNANT OR BREAST FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. DIRECTIONS Apply only amount needed to the oral mucosa to prevent or relieve pain. OTHER INFORMATION Store at 59° to 86°F (15° to 30°C). Protect from freezing. INACTIVE INGREDIENTS Flavoring, polyethylene glycol base, sodium saccharin. May contain blue #1, red #3, red #33, red #40, yellow #6, yellow #10. QUESTIONS OR COMMENTS? 1-800-333-3131 or 856-663-4700 www.keystoneind.com PRINCIPLE DISPLAY PANEL Bosworth ® ComfortCaine™ Topical Anesthetic 1 oz. (30g.) BOSLAB-176 0 Læs hele dokumentet