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

Stati Uniti - Ingliż - NLM (National Library of Medicine)

Ixtrih issa

Ingredjent attiv:
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A), ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)
Disponibbli minn:
MCLAREN MEDICAL INC
INN (Isem Internazzjonali):
MENTHOL, UNSPECIFIED FORM
Kompożizzjoni:
MENTHOL, UNSPECIFIED FORM 45 mg in 30 mL
Rotta amministrattiva:
OROPHARYNGEAL
Tip ta 'preskrizzjoni:
OTC DRUG
Indikazzjonijiet terapewtiċi:
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.
L-istatus ta 'awtorizzazzjoni:
OTC monograph not final
Numru ta 'awtorizzazzjoni:
43913-402-30

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.

----------

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 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

G-BUCAL-C

menthol, unspecified form and zinc chloride spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:439 13-40 2

Route of Administration

OROPHARYNGEAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MCLAREN MEDICAL INC

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED FORM -

UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED

FORM

45 mg

in 30 mL

ZINC CHLO RIDE (UNII: 8 6 Q357L16 B) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

30 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5)

CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERIN (UNII: PDC6 A3C0 OX)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

PEPPERMINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:439 13-40 2-

30 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part356

0 1/0 1/20 12

Labeler -

MCLAREN MEDICAL INC (013770591)

Revised: 6/2015

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