Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 55910-971-86
- Packager: OLD EAST MAIN CO.
- 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 December 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warning
- Keep out of Reach of Children
-
Directions
Adults and children 6 years of age and older:
- use twice daily after brushing your teeth with a toothpaste
- vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 miute 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 information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.
This product isnot intended to replace brushing or flossing
100% Satisfaction Guaranteed
If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.
(888)309-9030
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
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principal panel display
Since 1903
Rexall
Fluoride Anti-Cavity
Mouthwash
Sodium Fluoride and Acidulated
Phosphate Topical Solution
Alcohol-Free
6 BENEFITS
- Freshens breath
- Restores enamel
- Helps strengthen teeth to fight cavities
- Kills bad breath germs
- Burn free
- Cleans the entire mouth
IMPORTANT: read directions for proper use.
FRESH MINT
1 L (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-971 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 water (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM BENZOATE (UNII: OJ245FE5EU) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-971-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/01/2021 Labeler - OLD EAST MAIN CO. (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-971) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-971)