Label: ANTICAVITY RINSE- sodium fluoride mouthwash
- NDC Code(s): 0363-0014-44
- Packager: Walgreen 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 19, 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
- Warnings
- Keep out of reach of children.
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Directions
• adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
• remove cap
• pour 10 milliliters (10 mL mark on inside of cap); do not fill above the 10mL mark
• 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 - Inactive ingredients
- Other information
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Adverse reaction
Sealed with printed neckband for your protection
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse.
Questions or comments? 1-800-925-4733Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015
100% satisfaction guaranteed walgreens.com (c)2015 Walgreen Co.
Patent D604,628
004.002/004AE
- principal display panel
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INGREDIENTS AND APPEARANCE
ANTICAVITY RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION .05 kg in 100 L Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) D&C RED NO. 33 (UNII: 9DBA0SBB0L) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE (UNII: SE337SVY37) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0014-44 .5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/27/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/27/2002 Labeler - Walgreen Co (008965063) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(0363-0014) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(0363-0014)
