Label: ORAL ANTIVAVITY- sodium fluoride mouthwash
- NDC Code(s): 11822-5768-6
- Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
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 5, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- active ingredient
- Purpose
- Use
- Warnings
- Keep out or 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
-
SPL UNCLASSIFIED SECTION
This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.
*This product is not manufactured or distributed by Procter & Gamble, distributer of Crest Pro-Health Advanced Anticavity Fluoride Mouthwash
**This product is not intended to replace brushing or flossing
DISTRIBUTED BY: RITE AID,
30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com
SATISFACTION GUARANTEE
If you're not satisifed, we'll happily refund your money.
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principal panel display
Sealed with printed neckband for your protection
Compare to Crest® Pro-HealthTM Advanced Anticavity Fluoride Mouthwash*
FREE FROM
ALCOHOL FREE
PARABEN FREE
MULTI-ACTION
WITH FLUORIDE
ALCOHOL FREE
MOUTHWASH
ANTICAVITY FLUORIDE MOUTHRINSE
REFRESHING MINT
6 BENEFITS
kills bad breath
helps prevent cavities
helps strengthen enamel
cleans teach**
leaves mouth feeling clean
IMPORTANT:
read directions for proper use.
1L (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ORAL ANTIVAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-5768 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) glycerin (UNII: PDC6A3C0OX) cetylpyridinium chloride (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) phosphoric acid (UNII: E4GA8884NN) sodium benzoate (UNII: OJ245FE5EU) sucralose (UNII: 96K6UQ3ZD4) poloxamer 407 (UNII: TUF2IVW3M2) benzoic acid (UNII: 8SKN0B0MIM) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) propylene glycol (UNII: 6DC9Q167V3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-5768-6 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/05/2022 Labeler - Rite Aid (014578892) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11822-5768) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(11822-5768)