ONETOUCH REVOLUTION TOPICAL ANESTHETIC- benzocaine gel
HAGER WORLDWIDE, 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.
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Temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic devices
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a rare but 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 they or a child in your care develops:
Do not exceed reccommended dosage
Do not use if you have a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other ‘caine’ anesthetics
Do not use for more than 7 days unless directed by a doctor or dentist
Stop using and ask a doctor if swelling, rash or fever develops or if irritation, pain or redness persists of gets worse
Keep out of reach of children. In case of overdose, get medical help or Contact Poison Control Center right away
Adults and children 12 years and over. Press top of container and dispense 0.2 mL. Apply 0.2 mL of gel to the desired area using a cotton swab.
Children under 12 should be supervised by an adult.
Children under 2 years of age, consult a doctor.
ONETOUCH REVOLUTION
TOPICAL ANESTHETIC
benzocaine gel |
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Labeler - HAGER WORLDWIDE, INC. (009277971) |
Registrant - HAGER WORLDWIDE, INC. (009277971) |