Label: SCOPE STAY STRONG- sodium fluoride rinse
- NDC Code(s): 69423-859-33
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 12, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warning
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Directions
- Adults and children 6 years & older: Use twice a day after brushing your teeth with a toothpaste.
- Vigorously swish the 10 mL (2 teaspoonfuls) of 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 good rinsing habits (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
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SCOPE STAY STRONG
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-859 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) BENZOIC ACID (UNII: 8SKN0B0MIM) PHOSPHORIC ACID (UNII: E4GA8884NN) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) BASIC BLUE 1 (UNII: 92N74OA24D) BASIC YELLOW 5 (UNII: 07BP340B4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLOXAMER 407 (UNII: TUF2IVW3M2) ALCOHOL (UNII: 3K9958V90M) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:69423-859-33 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/24/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 01/24/2022 Labeler - The Procter & Gamble Manufacturing Company (004238200) Establishment Name Address ID/FEI Business Operations THE PROCTER & GAMBLE MANUFACTURING COMPANY 005279245 manufacture(69423-859) , pack(69423-859) Establishment Name Address ID/FEI Business Operations Merck KGaA 342249299 api manufacture(69423-859) Establishment Name Address ID/FEI Business Operations SUNLIT FLUO & CHEMICAL CO., LTD. CHUNG-LI FACTORY 658870890 api manufacture(69423-859)