Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
Beutlich Pharmaceuticals, LLC
ORAL
OTC DRUG
Oral Anesthetic for the temporary relief of occasional minor irritation and pain, associated with: - canker sores - sore mouth and throat - minor injury of the mouth and gums - minor dental procedures - minor irritation of the mouth and gums caused by dentures or orthodontic appliances Do not use: - if the product film is punctured or damaged - for teething - in children under 2 years of age
OTC monograph not final
HURRICAINE TOPICAL ANESTHETIC- BENZOCAINE GEL BEUTLICH PHARMACEUTICALS, LLC _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._ ---------- HURRICAINE UNIT DOSE GEL AND SWAB - CHERRY ACTIVE INGREDIENT Benzocaine 20% PURPOSE Oral Anesthetic USES for the temporary relief of occasional minor irritation and pain, associated with: canker sores sore mouth and throat minor injury of the mouth and gums minor dental procedures minor irritation of the mouth and gums caused by dentures or orthodontic appliances 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 if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. SORE THROAT WARNING: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly. DO NOT USE DO NOT USE: if the product film is punctured or damaged for teething in children under 2 years of age WHEN USING THIS PRODUCT avoid contact with eyes KEEP OUT OF REACH OF CHILDREN. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately. DIRECTIONS DIRECTIONS: Do not exceed recommended dosage. adults and children 2 years of a read_full_document