ANTICAVITY RINSE- sodium fluoride mouthwash 
Walgreen Co

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.

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Anticavity Fluoride Rinse  004.002/004AE

Active ingredient

Sodium fluoride 0.05% (0.02%w/v fluoride ion)

Purpose

Anticavity rinse

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, seek professional assistance or contact a Poison Control Center immediately.

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

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other information

•store at room temperature  

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? 1-800-925-4733

Distributed 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

Well at Walgreens

children's

ANTICAVITY - FLUORIDE

Mouth Rinse

Anticavity Fluoride Rinse

Helps prevent cavities

IMPORTANT: Read drections for proper use

Compae to Act Anticavity Kids Fluoride Rinse active ingredient

16.9 FL OZ (500 mL)

image description

ANTICAVITY RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.05 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0014-44.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/27/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/27/2002
Labeler - Walgreen Co (008965063)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(0363-0014)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(0363-0014)

Revised: 12/2022
Document Id: 7ef2f303-0c61-4231-b08d-9e390fff06ce
Set id: c56c5d65-ac64-4c99-bfe2-9ee2a43d5540
Version: 8
Effective Time: 20221219
 
Walgreen Co