G-BUCAL-C: Package Insert and Label Information

G-BUCAL-C- menthol, unspecified form and zinc chloride spray
MCLAREN MEDICAL INC

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 each 30 mL) Purpose
Menthol 0.15% Anesthetic/Analgesic
Zinc Chloride 0.1% Astringent

INDICATIONS

For the temporary relief of occasional minor throat irritation, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to minor dental procedures, pain due to minor irritations caused by dentures or orthodontic appliance, sore gums due to teething in infants and children 4 months of age and older.

DIRECTION FOR SPRAY

Spray G-Bucal-C several times as directed by physician or dentist to affected are in the mouth or lips. Children under 12 years of age should be supervised in the use of this product. Children under two years of age consult a doctor or dentist. As a gargle or mouthwash, ½ teaspoon in a half glass of warm water. Gargle swish around the mouth or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.

INACTIVE INGREDIENTS

Benzocaine, cetylpyridinium chloride, citric acid, glycerin, peppermint oil, polyethylene glycol, purified water, sodium citrate and sodium saccharin.

Each 30mL Contains:

Cetylpyridinium Chloride 30 mg
Benzocaine 600 mg
Menthol 45 mg
Zinc Chloride 30 mg

WARNINGS

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Do not use this product for more than 7 days unless directed by a dentist or doctor. If irritation, pain or redness persists or worsens, or if swelling, rash or fever develops, see your dentist or doctor promptly. DO NOT EXCEED RECOMMENDED DOSAGE. Do not use this product if you have history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics. Discontinue use and consult a doctor if irritation persists or increases or a rash appears on the skin. Fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your doctor. DO NOT USE IN OR NEAR THE EYES. In the event of accidental contact with eyes, flush immediately and continuously for ten minutes. See immediate medical attention if pain or irritation persists.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

PRINCIPAL DISPLAY PANEL — 30 mL Bottle Label

NDC-43913-402-30

G-Bucal-C Oral Solution Spray

Anesthetic • Astringent
Alcohol Free • Peppermint Flavor

1 FL OZ (30 mL)

For Dispensing Under
Pharmaceutical Supervision Only

McLaren Medical

Principal Display Panel -- 30 mL Bottle Label
(click image for full-size original)
G-BUCAL-C
menthol, unspecified form and zinc chloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43913-402
Route of Administration OROPHARYNGEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 45 mg in 30 mL
ZINC CHLORIDE (ZINC CATION) ZINC CATION 30 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
BENZOCAINE
CETYLPYRIDINIUM CHLORIDE
CITRIC ACID MONOHYDRATE
GLYCERIN
PEPPERMINT OIL
POLYETHYLENE GLYCOLS
WATER
SODIUM CITRATE
SACCHARIN SODIUM
Product Characteristics
Color Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43913-402-30 30 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 01/01/2012
Labeler — MCLAREN MEDICAL INC (013770591)

Revised: 06/2015 MCLAREN MEDICAL INC

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