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

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

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Produktens egenskaper Produktens egenskaper (SPC)
29-06-2015

Aktiva substanser:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A), ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)

Tillgänglig från:

MCLAREN MEDICAL INC

INN (International namn):

MENTHOL, UNSPECIFIED FORM

Sammansättning:

MENTHOL, UNSPECIFIED FORM 45 mg in 30 mL

Administreringssätt:

OROPHARYNGEAL

Receptbelagda typ:

OTC DRUG

Terapeutiska indikationer:

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.

Bemyndigande status:

OTC monograph not final

Produktens egenskaper

                                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._
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G-BUCAL-C
DRUG FACTS
ACTIVE INGREDIENTS (IN
EACH 30 ML)
PURPOS E
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 pr
                                
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