GUMSOL - benzocaine, zinc chloride spray 
Kramer Novis

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.

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GUMSOL

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 olderDry affected area with absorbent cotton.

Spray 4 times daily or as directed by physician.

Children under 12 years of ageShould be supervised in the usage of this product.
Children under 2 years of ageDo 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

Spray

Alcohol Free

Manufactured in the USA for

Kramer Novis, San Juan, PR 00917

Packaging

Gumspnew

GUMSOL  
benzocaine, zinc chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-714
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE1.5 g  in 30 mL
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.03 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-714-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/28/2014
Labeler - Kramer Novis (090158395)

Revised: 11/2018
Document Id: 9f4c663e-aa3c-4190-83c7-61ec6f0a4eb7
Set id: 3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf
Version: 2
Effective Time: 20181126
 
Kramer Novis