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NDC 23636-1002-01 New NBF GINGIVAL Gel 9.01; .4 g/100g; g/100g Details
New NBF GINGIVAL Gel 9.01; .4 g/100g; g/100g
New NBF GINGIVAL Gel is a DENTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by NanoCureTech. The primary component is GLYCERIN; LEVOMENTHOL.
Product Information
| NDC | 23636-1002 |
|---|---|
| Product ID | 23636-1002_2dbfe6d0-69b2-47d1-9d5c-930f5bc1af7e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | New NBF GINGIVAL Gel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Glycerin, Menthol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | DENTAL |
| Active Ingredient Strength | 9.01; .4 |
| Active Ingredient Units | g/100g; g/100g |
| Substance Name | GLYCERIN; LEVOMENTHOL |
| Labeler Name | NanoCureTech |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 23636-1002-01 (23636100201)
| NDC Package Code | 23636-1002-1 |
|---|---|
| Billing NDC | 23636100201 |
| Package | 1 TUBE in 1 CARTON (23636-1002-1) / 30 g in 1 TUBE |
| Marketing Start Date | 2017-11-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ce2483f4-9ff3-42a8-81ba-c91ddedd6169 Details
Uses
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.
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| NEW NBF GINGIVAL GEL
glycerin, menthol gel |
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| Labeler - NanoCureTech (557799555) |