Label: SODIUM FLUORIDE mouthwash
- NDC Code(s): 53942-581-86
- Packager: Demoulas Super Markets, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 June 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Claims
- Active ingredient
- Purpose
- Use
- Warning
- Keep out of reach of children.
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Directions
Adults and children 6 years of age and older:
- use twice a day after brushing your teeth with a toothpaste
- vigorously swish 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
- Adverse reaction
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Principal Panel Display
Sealed With Printed Neckband For Your Proection
MARKET BASKET
"MORE FOR YOUR DOLLAR"
compare to Act Restoring Anticavity Fluoride Mouthwash*
Restoring Anticavity Fluoride Mouthwash
ANTICAVITY MOUTHWASH
Restores enamel
Helps avoid tooth decay
Helps remineralize soft spots
Freshens breath
IMPORTANT: read directions for proper use.
33.8 FL OZ (1 L)
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INGREDIENTS AND APPEARANCE
SODIUM FLUORIDE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-581 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE (UNII: SE337SVY37) POLYSORBATE 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53942-581-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/05/2023 Labeler - Demoulas Super Markets, Inc (007869647) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(53942-581) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(53942-581)