Label: GELATO PERIO MAINTENANCE RINSE- stannous fluoride concentrate
- NDC Code(s): 68400-202-10
- Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated April 22, 2024
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- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- Indications and Usage:
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Warnings:
- Keep out of reach of children.
- Do not swallow. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
- Do not use until diluted.
- This product may produce surface staining of the teeth.
- This product may produce surface staining of the teeth. Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
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Directions:
Adults and children 6 years of age and older:
- Do not use before mixing with water. Use immediately after preparing the rinse.
- Shake concentrate well before mixing with water.
- Remove cap and replace with pump.
- Rotate spout counter clockwise to extend.
- Depress pump until rinse comes to the tip of the pump.
- Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
- Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
- Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 6 years of age: Consult a dentist or doctor.
- Inactive Ingredients:
- Other Information:
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GELATO PERIO MAINTENANCE RINSE
stannous fluoride concentrateProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-202 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.34 g in 283.5 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color white (heavy liquid) Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68400-202-10 283.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2013 Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301) Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301) Establishment Name Address ID/FEI Business Operations Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 014769301 manufacture(68400-202) , label(68400-202)
