Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-3705-4 - Packager: Rite Aid
- 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 26, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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Directions
Adults and children 12 years of age and older:
- use twice daily after brushing your teeth with 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 12 years of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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Principal Display Panel
RITE AID PHARMACY
Sealed With Printed Neckband For Your Protection
IMPORTANT: READ DIRECTIONS FOR PROPER USE
*Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash
Anticavity Mouthwash
Sodium Fluoride and Acidulated Phosphate Topical Solution
fresh mint
helps prevent cavities
restores enamel
helps strengthen teeth
helps kill bad breath germs
leaves the mouth feeling clean
1 LITER ( 33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-3705 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) SODIUM LAURYL SULFATE (UNII: 368GB5141J) EUCALYPTOL (UNII: RV6J6604TK) METHYL SALICYLATE (UNII: LAV5U5022Y) THYMOL (UNII: 3J50XA376E) PHOSPHORIC ACID (UNII: E4GA8884NN) sucralose (UNII: 96K6UQ3ZD4) MENTHOL (UNII: L7T10EIP3A) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) 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:11822-3705-4 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/04/1994 Labeler - Rite Aid (014578892) Registrant - Vi Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon 790752542 manufacture(11822-3705)