Label: FLUORIDE MOUTHWASH SOFT MINT- sodium fluoride mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 79763-002-01 - Packager: Swiss Shine Beauty AG
- Category: HUMAN OTC DRUG LABEL
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 August 3, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Shake well before use.
- Adults and children 6 years of age and older: Use once a day after brushing yout teeth with a toothpaste.
- Vigorously swish 10 milliliters 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.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLUORIDE MOUTHWASH SOFT MINT
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79763-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ZINC LACTATE (UNII: 2GXR25858Y) POLOXAMER 407 (UNII: TUF2IVW3M2) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) HYDROCHLORIC ACID (UNII: QTT17582CB) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79763-002-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/21/2020 Labeler - Swiss Shine Beauty AG (480422958) Establishment Name Address ID/FEI Business Operations System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH 328825757 manufacture(79763-002) Establishment Name Address ID/FEI Business Operations Marvinpac SA 482060329 pack(79763-002)
