Label: PH7 GEL MINT- topical neutral fluoride gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10866-0093-1 - Packager: Pascal Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated March 26, 2015
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- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL
- Contains:
- Indications
- Contraindications
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Warnings and Precautions
Keep out of reach of children. For topical intraoral use only. For professionally applied, in-office fluoride treatment only.
- Not for systemic treatement. Do not swallow.
- Do not use on patients with an allergy to fluoride
- pH7 Gel contains artificial flavor and color; confirm that no known patient allergies exist.
- Special care should be used when administering to children under 6 years of age so that gel is not swallowed.
- Contact with abraded or sensitive oral tissue may produce discomfort.
- If more than is ordinarily used for treatment is swallowed, adminster calcium such as milk and contact your local Poison Control Center immediately.
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Dosage and Directions for Use
Usual dosage is approximately 2.75-9.0 grams of pH7 Gel per dual arch treatment depending on tray size
- After prophylaxis remove excess fluid from teeth.
- Fill applicator tray 1/3 full with gel.
- Insert filled tray into patient's mouth and instruct to bite down gently for one minute or up to four minutes.
- After treatment time is completed remove tray and have patient expectorate residual gel.
- For maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes.
Repeat treatment at least once or twice a year. For patients with rampant or active caries, repeat treatment once or twice every six months.
If contents have become frozen, warm to room temperature and shake well before using.
- Other Safety Information
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INGREDIENTS AND APPEARANCE
PH7 GEL MINT
topical neutral fluoride gel gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10866-0093 Route of Administration TOPICAL, BUCCAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion 9.05 mg in 1 g Product Characteristics Color green Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10866-0093-1 473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/1993 Labeler - Pascal Company, Inc. (009260217) Establishment Name Address ID/FEI Business Operations Pascal Company, Inc. 009260217 manufacture(10866-0093)
