Gumsol description, usages, side effects, indications, overdosage, supplying and lots more!

Gumsol

Kramer Novis

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients (in 30 mL)                    Purpose

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

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



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

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.

Uses


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 Spray

Anesthetic

Astringent

Alcohol free

30 mL

1 Fl. Oz.

NDC 52083-713-01

KRAMER-NOVIS

Principal Display Panel

Gumsol

Benzocaine, Zinc Chloride SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52083-714
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 1.5 g
ZINC CHLORIDE 0.03 g

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
cetylpyridinium chloride
GLYCERIN
MENTHOL
METHYLPARABEN
propylene glycol
PROPYLPARABEN
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52083-714-01 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2014-02-28


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Be sure to consult your doctor before taking any medication!
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