OTC Medication Information: Anticavity Fluoride Rinse

ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
Target Corporation

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.

Active ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 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 6 years of age: consult a dentist or doctor

Other information

  • store at controlled room temperature 20⁰ -25⁰ C (68⁰ — 77⁰ F)
  • cold weather may temporarily cloud this product

Inactive ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disosium phosphate, red 40, blue 1

Questions?

Call 1-800-910-6874

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash.

Distributed by Target Corp., Mpls., MN 55403
Made in U.S.A. with US and foreign components
2015 Target Brands, Inc.
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anticavity mouthwash

Compare to active ingredient in Listerine Total Care Anticavity Mouthwash

6 benefits

  • helps prevent cavities
  • restores enamel
  • helps strengthen teeth
  • kills bad breath germs
  • freshens breath
  • cleans the entire mouth

UP & UP

MINT FLAVOR

33.8 FL OZ (1 L)

image descriptionimage description
ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-163
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
EUCALYPTOL
METHYL SALICYLATE
MENTHOL
PHOSPHORIC ACID
SACCHARIN SODIUM
thymol
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SUCRALOSE
FD&C RED NO. 40
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11673-163-86 1000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 04/06/1994
Labeler — Target Corporation (006961700)
Registrant — Vi Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi Jon 790752542 manufacture (11673-163)

Revised: 04/2020 Target Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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