Label: NEW NBF GINGIVAL GEL- glycerin, menthol gel
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- NDC Code(s): 23636-1002-1
- Packager: NanoCureTech
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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
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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
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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.
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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.
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INGREDIENTS AND APPEARANCE
NEW NBF GINGIVAL GEL
glycerin, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23636-1002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Color brown (light brown) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23636-1002-1 1 in 1 CARTON 11/27/2017 12/14/2023 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/27/2017 12/14/2023 Labeler - NanoCureTech (557799555)
