Gumsol
FDA Label NDC 52083-713
11 label sections · Submitted to the FDA by Kramer Novis · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Gumsol (NDC 52083-713). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in 30 ml), purposes, use, warnings, otc - keep out of reach of children, directions, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In 30 Ml)
Benzocaine (5%)
Zinc Chloride (0.1%)
Purposes
Anesthetic
Astringent
Use
Temporarily relieves pain due to toothaches, canker sores or minor mouth injuries 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 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.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
| 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. |
Other Information:
• 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.
Inactive Ingredients
Aspartame, cetylpyridinium chloride, glycerin, menthol, methylparaben, peppermint flavor, propylene glycol, propylparaben, and water (purified).
Questions Or Comments?
Kramer Novis San Juan, PR 00917. Monday to Friday
(8am-4pm). 787-767-2072 www.kramernovis.com
Packaging
Gumsnew (Gum713nw)
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