Label: NEW NBF GINGIVAL GEL- glycerin, menthol gel

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated May 31, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    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)