Country: United States
Language: English
Source: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
Inter-Med, 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.
OTC monograph not final
VISTACAINE TOPICAL ANESTHETIC- BENZOCAINE GEL INTER-MED, 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._ ---------- ACTIVE INGREDIENTS (IN EACH GRAM) Benzocaine 200 mg PURPOSE Oral Anesthetic USE 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; or 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, grey or blue colored 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. Keep Out of Reach of Children. DIRECTIONS Apply only amount needed to the oral mucosa to prevent or relieve pain. OTHER INFORMATION Store at 59º -86°F (15 - 30°C). Protect from freezing. INACTIVE INGREDIENTS flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #5, red #3, red #28, red #40, yellow #5 (tartrazine), as a color additive. QUESTIONS OR COMMENTS? 1-262-636-9755 VISTACAINE TOPICAL ANESTHETIC benzocaine gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE Read the complete document