Gumsol
FDA Label NDC 52083-713

Full FDA labeling including 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

    • Children under 12 years of age:

    • Should be supervised in the usage of this product.

      • Children under 2 years of age:

      • Consult a dentist or physician.

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

Oral Topical Solution

Anesthetic

Astringent

Alcohol free

30 mL

1 Fl. Oz.

NDC 52083-713-01

KRAMER-NOVIS

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