GUMSOL
- benzocaine, zinc chloride solution
Kramer Novis
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.
----------
Temporarily relieves pain due to toothaches, canker sores or minor mouth injuries of the mouth and gums caused by dentures or orthodontic appliances.
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" anesthetic. If skin reaction occurs, stop use and seek medical help right away.
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
Do not use (unless directed by a doctor): • more than directed • for more than 7 days • in children under 2 years of age • for teething.
Stop use and see a doctor promptly if: • sore mouth symptoms do not improve in 7 days
• irritation, pain or redness persist or worsen
• swelling, rash or fever develops.
If pregnant or breast-feeding, ask a health professional before use.
Adults and children 12 years of age and older |
Dry affected area with absorbent cotton. Apply 4 times daily with |
Children under 12 years of age | Should be supervised in the usage of this product. |
Children under 2 years of age | Do not use. |
• Phenylketonurics: Contains phenylalanine 2.5mg/mL.
• Store at controlled room temperature: 15°C-30°C (59°F-86°F)
• Tamper Evident:Do not use if imprinted foil seal over bottle opening is torn, broken, or missing.
Aspartame, cetylpyridinium chloride, glycerin, menthol, methylparaben, peppermint flavor, propylene glycol, propylparaben, and water (purified).
GUMSOL
benzocaine, zinc chloride solution |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - Kramer Novis (090158395) |