Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepack 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 - pale - grey or blue colored skin, as this may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
OTC monograph not final
COMFORTCAINE- BENZOCAINE GEL MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPACK 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 - STRAWBERRY _ACTIVE INGREDIENTS (IN EACH GRAM)_ Benzocaine 200 mg _PURPOSE_ Oral Anesthetic _USES_ 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 PRACITIONER if the following symptoms appear. weakness confusion headache difficulty breathing pale grey or blue colored skin, as this 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 teh oral mucosa to prevent or relieve pain. _OTHER INFORMATION_ Store at 59º - 86ºF (15-30ºC). 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 PRINCIPAL DISPLAY PANEL Bosworth® ComfortCaine™ Topical Anesthetic 1 oz. (30g.) BOSLAB-176 0516PR930 COMFORTC Baca dokumen lengkapnya