New NBF GINGIVAL Gel

Manufacturer
NanoCureTech
Effective date
2021-05-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:44:05

Label at a glance#

ProductNew NBF GINGIVAL Gel
Active ingredientGLYCERIN, LEVOMENTHOL
Label structure11 sections

Indications and uses

For the temporary relief of  • occasional minor irritation, pain, sore mouth, sore throat • pain associated with canker sores • minor discomfort and protection of irritated areas in sore mouth and sore throat  • pain due to minor dental procedures, minor irritation or injury of the mouth and gums

Dosage and administration

• Adults and children 2 years of age and older: Apply the gel diluted with 2 or 3 parts of water to the affected area. Gargle, swish around in the mouth or allow to remain in place for at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. • Children under 12 years of age: Should be supervised in the use of this product.  • Children under 3 years of age: Consult a denti...

Storage and handling

• Store at room temperature (1-30 ​° C) – (34-86 ​° F). • Do not use if seal under cap is broken or missing.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 9.01%
Menthol 0.40%

Purpose

OTC - PURPOSE SECTION

Oral demulcent
Oral Pain Reliever

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of  • occasional minor irritation, pain, sore mouth, sore throat • pain associated with canker sores • minor discomfort and protection of irritated areas in sore mouth and sore throat  • pain due to minor dental procedures, minor irritation or injury of the mouth and gums

Warnings

WARNINGS SECTION

Do not use full strength, dilute with two or three volumes of water.
Stop use and ask a doctor or dentist • if sore throat is severe, persists more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea or vomiting  • if sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
Do not exceed recommended dosage.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If an excessive amount of gel is accidentally swallowed or in case of allergic reaction, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: Apply the gel diluted with 2 or 3 parts of water to the affected area. Gargle, swish around in the mouth or allow to remain in place for at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.
• Children under 12 years of age: Should be supervised in the use of this product. 

• Children under 3 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera (Aloe barbandesis) leaf extract, Ascorbic acid, Calcium glycerophosphate, Cellulose gum, Eucalyptus oil, Grapefruit (Citrus paradisi) extract, Green tea (Camellia sinensis) leaf extract, Hydrated silica, PEG-32, Peppermint oil, Pot Marigold (Calendula offcinalis) leaf extract, Propolis extract, Sorbitol, Steviol glycosides, Tocopheryl acetate, Water, Xylitol.

​Other information

STORAGE AND HANDLING SECTION

• Store at room temperature (1-30​°C) – (34-86​°F).
• Do not use if seal under cap is broken or missing.

​Questions?

OTC - QUESTIONS SECTION

Tel : +82-2-474-82224
Mon-Fri (8 am -5 pm).

SPL UNCLASSIFIED SECTION

Technology provider and distributer:

NanoCureTech Co. Ltd.
#502, 24, Yeokjeon-gil, Yangpyenong-eup, Yangpyenog-gu, Gyonggido, South Korea, Zip Code: 134-864.

Country of origin: South Korea

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23636-1002-12020-06-18C16284748780-19d75b9cf-eb22-f424-e053-dadaa90a57ceNew NBF GINGIVAL GEL
23636-1002-12020-01-31C16284748780-19d75b9cf-eb22-f424-e053-dadaa90a57ceNew NBF GINGIVAL GEL

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23636-100223636-1002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

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
2dbfe6d0-69b2-47d1-9d5c-930f5bc1af7ece2483f4-9ff3-42a8-81ba-c91ddedd61692021-05-31WarningsExact identifier
spl id: 2dbfe6d0-69b2-47d1-9d5c-930f5bc1af7e
spl set id: ce2483f4-9ff3-42a8-81ba-c91ddedd6169

Reported adverse events (FAERS/openFDA)#

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