البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y), BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Wal-Mart Stores Inc
DENTAL
OTC DRUG
Purpose Oral pain reliever Oral pain reliever Antiseptic Use · for the temporary relief of pain due to toothaches · to help protect against infection of minor oral irritation Do not use · more than directed · for more than 7 days unless told to do so by a dentist or doctor · for teething · in children under 2 years of age Stop use and ask a doctor if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs
OTC monograph not final
EQUATE SEVERE TOOTHACHE AND GUM RELIEF- BENZOCAINE, MENTHOL, BENZALKONIUM CHLORIDE GEL WAL-MART STORES 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._ ---------- 5820361 EQUATE SEVERE TOOTHACHE & GUM RELIEF _DRUG FACTS_ _DRUG FACTS_ _ACTIVE INGREDIENTS_ Benzocaine 20% Menthol 0.5% Benzalkonium Chloride 0.1% _PURPOSE_ Oral pain reliever Oral pain reliever Antiseptic _USE_ · for the temporary relief of pain due to toothaches · to help protect against infection of minor oral irritation _WARNINGS_ METHEMOGLOBINEMIA WARNING: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy ALLERGY ALERT: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics DO NOT USE · more than directed · for more than 7 days unless told to do so by a dentist or doctor · for teething · in children under 2 years of age STOP USE AND ASK A DOCTOR IF • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ • cut open tip of tube on score mark • adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor • children be اقرأ الوثيقة كاملة