מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)
Blistex Inc
ORAL
OTC DRUG
- for the temporary relief of pain due to toothaches, canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums
OTC monograph not final
KANKA SOFTBRUSH- BENZOCAINE AND ZINC CHLORIDE GEL BLISTEX 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._ ---------- KANKA SOFTBRUS H _DRUG FACTS_ _ACTIVE INGREDIENTS_ _PURPOSE_ Benzocaine 20.0% (w/w) Oral anesthetic/analgesic Zinc Chloride 0.1% (w/w) Oral astringent US ES for the temporary relief of pain due to toothaches, canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums 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 for teething in children under 2 years of age WHEN USING THIS PRODUCT do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly. do not exceed recommended dosage. KEEP OUT OF REACH OF CHILDREN. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS adults and children 2 years of age and older: ® twist base clockwise to dispense. It may take up to 10 full turns to dispense the initial dose, but subsequent uses should require less than 1 turn. to clean brush tip, rinse with cold wat קרא את המסמך השלם