G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC]

G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC]
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NDC 43913-402-30
Set ID 31690548-0a55-4d72-8733-591ba3a9be92
Category HUMAN OTC DRUG LABEL
Packager MCLAREN MEDICAL INC
Generic Name
Product Class
Product Number
Application Number PART356
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    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 Chloride30 mg
    Benzocaine600 mg
    Menthol45 mg
    Zinc Chloride30 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
  • INGREDIENTS AND APPEARANCE
    G-BUCAL-C 
    menthol, unspecified form and zinc chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43913-402
    Route of AdministrationOROPHARYNGEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM45 mg  in 30 mL
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43913-402-3030 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35601/01/2012
    Labeler - MCLAREN MEDICAL INC (013770591)