FDA Label for G-bucal-c
View Indications, Usage & Precautions
G-bucal-c Product Label
The following document was submitted to the FDA by the labeler of this product Mclaren Medical Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
DRUG FACTS
Otc - Purpose
| 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.
Otc - Keep Out Of Reach Of Children
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
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