NEW NBF GINGIVAL GEL- glycerin, menthol gel

Drug Details [pdf]

Drug Facts
Active ingredients

Glycerin 9.01%
Menthol 0.40%
Purpose

Oral demulcent
Oral Pain Reliever
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
Warnings

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.
KEEP OUT OF REACH OF CHILDREN

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

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

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

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

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

NEW NBF GINGIVAL GEL
glycerin, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23636-1002
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	9.01 g in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	0.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GRAPEFRUIT (UNII: O82C39RR8C)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEPPERMINT OIL (UNII: AV092KU4JH)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SORBITOL (UNII: 506T60A25R)
STEVIOL (UNII: 4741LYX6RT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	brown (light brown)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 23636-1002-1	1 in 1 CARTON	11/27/2017
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	11/27/2017

Labeler - NanoCureTech (557799555)

NEW NBF GINGIVAL GEL- glycerin, menthol gel

New NBF GINGIVAL Gel by

Drug Labeling and Warnings

Drug Details [pdf]