Gumsol

Gumsol
SPL v2
SPL
SPL Set ID 3ef75f3c-cc00-4b39-9249-161da76bb9a7
Route
ORAL
Published
Effective Date 2018-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (1.5 g) Zinc Cation (0.03 g)
Inactive Ingredients
Aspartame Cetylpyridinium Chloride Glycerin Menthol, Unspecified Form Methylparaben Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-02-28

Description

Benzocaine (5%) Zinc Chloride (0.1%)

Purpose

Anesthetic Astringent


Medication Information

Purpose

Anesthetic Astringent

Description

Benzocaine (5%) Zinc Chloride (0.1%)

Use

Temporarily relieves pain due to toothaches, canker sores or minor mouth injuries of the mouth and gums caused by dentures or orthodontic appliances.

Section 42229-5

Oral Topical Solution

Alcohol Free

Manufactured in the USA for

Kramer Novis, San Juan, PR 00917

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Purposes

Anesthetic

Astringent

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.

Packaging

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.

Drug Facts

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

Active Ingredients (in 30 Ml)

Benzocaine (5%)

Zinc Chloride (0.1%)


Structured Label Content

Use

Temporarily relieves pain due to toothaches, canker sores or minor mouth injuries of the mouth and gums caused by dentures or orthodontic appliances.

Section 42229-5 (42229-5)

Oral Topical Solution

Alcohol Free

Manufactured in the USA for

Kramer Novis, San Juan, PR 00917

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Purposes

Anesthetic

Astringent

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.

Packaging

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.

Drug Facts

Other Information: (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Kramer Novis San Juan, PR 00917. Monday to Friday

(8am-4pm). 787-767-2072  www.kramernovis.com

Active Ingredients (in 30 Ml) (Active ingredients (in 30 mL))

Benzocaine (5%)

Zinc Chloride (0.1%)


Advanced Ingredient Data


Raw Label Data

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