FDA Label for Gumsol
View Indications, Usage & Precautions
Gumsol Product Label
The following document was submitted to the FDA by the labeler of this product Kramer Novis. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients (in 30 mL) Purpose
Benzocaine 5% ............................................. Anesthetic
Zinc Chloride 0.1% ....................................... Astringent
Otc - Purpose
Uses
Temporarily relieves:
- Toothache, canker sore, minor dental procedures, or minor mouth injury or irritation of the mouth and gums caused by dentures or orthodontic appliances.
- Sore gums due to teething in infants and children 4 months of age or older.
Warnings
Warnings
Do not exceed recommended dosage. Avoid contact with eyes. Severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.
Otc - Do Not Use
Do not use: (unless directed by a doctor)
- For more than 7 days.
- If you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine of other "caine" anesthetics. Stop use and see a doctor promptly:
- If mouth symptoms do not improve in 7 days
- If irritation, pain, or redness persist or worsens
- If swelling, rash or fever develops
Otc - Pregnancy Or Breast Feeding
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.
Dosage & Administration
Directions:
Dry affected area with absorbent cotton. Apply with cotton applicator or spray.
Adults and children 12 years or over:
- Apply 4 times daily or as directed by a dentist or physician.
- Should be supervised in the usage of this product.
- Consult a dentist or physician.
Children under 12 years of age:
Children under 2 years of age:
Indications & Usage
Other information
Phenylketonurics: Contains phenylalanine 2.5 mg/mL
Store at controlled room temperature 15-30°C (59-86°F).
Tamper Evident Feature: Do not use if imprinted foil seal over bottle opening is torn, broken, or missing.
Inactive Ingredient
Inactive ingredients:
Aspartame, cetylpyridinium chloride, glycerin, menthol, methylparaben, peppermint flavor, propylene glycol, propylparaben, and water (purified).
Otc - Questions
Questions of comments?:
Kramer-Novis, San Juan PR, 1-787-767-2072
Principal Display Panel
Gumsol Spray
Anesthetic
Astringent
Alcohol free
30 mL
1 Fl. Oz.
NDC 52083-713-01
KRAMER-NOVIS
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