Anticavity: Package Insert and Label Information

ANTICAVITY- sodium fluoride mouthwash
Walgreens

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.

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredients

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

For this product

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 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

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Questions?

Call 1-800-925-4733

disclaimer

Walgreens Pharmacist Survey Study, November 2016

This product is not manufactured or distributed by Chattem Inc.,

distributor of ACT Restoring Anticavity Fluoride Mouthwash Cool Mint.

Adverse Reactions

DISTRIBUTED BY: WALGREEN CO

200 WILMOT RD., DEERFIELD, IL 60015

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WALGREENS PHARAMACIST RECOMMENDED

ANICAVITY

Mouth Rinse

With Sodium Flouride

  • Helps prevent cavities & strengthen teeth
  • Restored enamel
  • Freshens breath

REFRESHING MINT

Compare to Act Restoring Anticavity

Fluoride Mouthwash active ingredient

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 L)

image description
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ANTICAVITY
sodium fluoride mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0581
Route of Administration oral DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
PROPYLENE GLYCOL
SODIUM BENZOATE
SODIUM PHOSPHATE
POLYSORBATE 20
SACCHARIN SODIUM
CETYLPYRIDINIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
EDETATE CALCIUM DISODIUM ANHYDROUS
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0581-86 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 03/03/2017
Labeler — Walgreens (008965063)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (0363-0581)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (0363-0581)

Revised: 05/2022 Walgreens

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