GUMSOL- benzocaine, zinc chloride solution

Gumsol by

Drug Labeling and Warnings

Gumsol by is a Otc medication manufactured, distributed, or labeled by Kramer Novis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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.

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 ; cotton applicator.

• 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

SPL UNCLASSIFIED SECTION

Oral Topical Solution

Alcohol Free

Manufactured in the USA for

Kramer Novis, San Juan, PR 00917

Packaging

INGREDIENTS AND APPEARANCE

GUMSOL  
benzocaine, zinc chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-713
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	1.5 g  in 30 mL
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.03 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-713-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/28/2014

Labeler - Kramer Novis (090158395)