Label: G-BUCAL-C- menthol, unspecified form and zinc chloride spray
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated June 29, 2015
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
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.
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
INGREDIENTS AND APPEARANCE
menthol, unspecified form and zinc chloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43913-402 Route of Administration OROPHARYNGEAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 45 mg in 30 mL ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 30 mg in 30 mL Inactive Ingredients Ingredient Name Strength BENZOCAINE (UNII: U3RSY48JW5) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43913-402-30 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 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)