G-BUCAL-C

Manufacturer
MCLAREN MEDICAL INC
Effective date
2015-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:38

Label at a glance#

ProductG-BUCAL-C
Active ingredientMENTHOL, UNSPECIFIED FORM, ZINC CHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each 30 mL)Purpose
Menthol 0.15%Anesthetic/Analgesic
Zinc Chloride 0.1%Astringent

INDICATIONS

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

WARNINGS SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 30 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291083benzocaine 2 % / cetylpyridinium Cl 0.1 % / menthol 0.15 % / zinc chloride 0.1 % Mucosal SprayPSN1
1291083benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 1.5 MG/ML / zinc chloride 1 MG/ML Mucosal SpraySCD1
1291083benzocaine 2 % / cetylpyridinium Cl 0.1 % / menthol 1.5 % / zinc chloride 0.1 % Mucosal SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43913-402-302020-01-31C16284748780-19d75b9d0-793f-f424-e053-dadaa90a57ceG-BUCAL-C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43913-402-30G-BUCAL-C30 mL in 1 BOTTLE, SPRAYSPRAY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43913-402G-BUCAL-C (MENTHOL, UNSPECIFIED FORM AND ZINC CHLORIDE) SPRAY [MCLAREN MEDICAL INC]1Legacy NDC, 1 package rows20150922_31690548-0a55-4d72-8733-591ba3a9be92.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43913-402-30ML - Milliliter43913-402df3d8a71-faa8-4db2-ba22-9175b234e1fb12016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOL, UNSPECIFIED FORMACTIVE INGREDIENTL7T10EIP3A1
ZINC CHLORIDEACTIVE INGREDIENT86Q357L16B1
MENTHOL, UNSPECIFIED FORMACTIVE MOIETYL7T10EIP3A1
ZINC CATIONACTIVE MOIETY13S1S8SF371
BENZOCAINEINACTIVE INGREDIENTU3RSY48JW51
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49P1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43913-40243913-402-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 224 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRACARDIAC1.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EFFERVESCENT / ORAL460 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / RESPIRATORY (INHALATION)8 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAMUSCULAR28 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8cf80886-2241-4e7c-af0e-50da491bf38e31690548-0a55-4d72-8733-591ba3a9be922015-06-29WarningsExact identifier
spl id: 8cf80886-2241-4e7c-af0e-50da491bf38e
spl set id: 31690548-0a55-4d72-8733-591ba3a9be92

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.