Skip to Content

← See all Gumsol brands

Gumsol by Kramer Novis

Dosage form: solution
Ingredients: BENZOCAINE 1.5g in 30mL, ZINC CHLORIDE 0.03g in 30mL
Labeler: Kramer Novis
NDC Code: 52083-713

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.

Drug Facts

Active Ingredients (in 30 mL)                    Purpose

Benzocaine 5% ............................................. Anesthetic

Zinc Chloride 0.1% ....................................... Astringent



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

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.

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


If pregnant or breast-feeding, ask a health professional before use.


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.



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.


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 ingredients:
Aspartame, cetylpyridinium chloride, glycerin, menthol, methylparaben, peppermint flavor, propylene glycol, propylparaben, and water (purified).

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

GUMSOL  
benzocaine, zinc chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-713
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE1.5 g  in 30 mL
ZINC CHLORIDE (ZINC CATION) ZINC CATION0.03 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CETYLPYRIDINIUM CHLORIDE 
GLYCERIN 
MENTHOL 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:52083-713-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/28/2014
Labeler - Kramer Novis (090158395)

Revised: 02/2014
 
Kramer Novis

← See all Gumsol brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide