NEW NBF GINGIVAL GEL- glycerin, menthol gel 
NanoCureTech

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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New NBF GINGIVAL GEL

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. 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).

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

image description

NEW NBF GINGIVAL GEL 
glycerin, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23636-1002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN9.01 g  in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL0.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 1600 (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
Colorbrown (light brown) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23636-1002-11 in 1 CARTON11/27/201712/14/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/27/201712/14/2023
Labeler - NanoCureTech (557799555)

Revised: 5/2021
Document Id: 2dbfe6d0-69b2-47d1-9d5c-930f5bc1af7e
Set id: ce2483f4-9ff3-42a8-81ba-c91ddedd6169
Version: 3
Effective Time: 20210531
 
NanoCureTech