Label: ANTICAVITY- sodium fluoride mouthwash
- NDC Code(s): 55910-163-86
- Packager: Dolgencorp, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 9, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Tamper Evident Statement
- Active ingredient
- Purpose
- Use
- WARNINGS
- 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 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 information
- Inactive ingredients
-
Adverse Reaction
Since 1903 Rexall® is a registered trademark of Rexall Sundown, Inc.
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
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
DSP-TN-21091
DSP-MO-20087DSP-MO-28
SDS-MO-20068
- Principal Panel Display
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) EUCALYPTOL (UNII: RV6J6604TK) METHYL SALICYLATE (UNII: LAV5U5022Y) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN SODIUM (UNII: SB8ZUX40TY) THYMOL (UNII: 3J50XA376E) 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:55910-163-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/13/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 05/13/2006 Labeler - Dolgencorp, LLC (068331990) Registrant - Vi-Jon, LLC (088520668) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-163) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-163)
