Label: ANTICAVITY- sodium fluoride mouthwash
- NDC Code(s): 55301-435-43, 55301-435-45
- Packager: Your Military Exchanges
- 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 February 16, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Use
- Warnings
- 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
- Other information
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SPL UNCLASSIFIED SECTION
SEALED WITH PRINTED NECK BAND FOR YOUR PROTECTION
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Vibrant Anticavity Mouthrinse
Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightl or release air when opened.
"Satisfaction guaranteed or your money back."
Manufactured for your Military Exchanges
By Vi-Jon, 8515 Oage Avenue
St. Louis, MO 63114
- Principal display panel
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-435 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) HYDROGEN PEROXIDE (UNII: BBX060AN9V) POLOXAMER 407 (UNII: TUF2IVW3M2) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) MENTHOL (UNII: L7T10EIP3A) PHOSPHORIC ACID (UNII: E4GA8884NN) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-435-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/28/2015 2 NDC:55301-435-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/28/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/01/2015 Labeler - Your Military Exchanges (001695568) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55301-435) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55301-435)
