ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM- sodium fluoride rinse 
Greenbrier International, Inc.

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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Assured Kids Anticavity Fluoride Rinse Bubblegum

Drug Facts

Active Ingredients

Sodium fluoride 0.05% (Fluoride ion-0.0226%)

Purpose

Anticavity rinse

Use aids in the prevention of dental cavities.

Warning

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Inactive ingredients Benzyl Alcohol, Calcium disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Poloxamer 407, Polysorbate 80, Propylene Glycol, Red 33, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water

Other information

*Anticavity Fluoride Rinse is not manufactured or distributed by Personal Products Company division or McNeil-PPC., distributor or Act®

DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC.

CHESAPEAKE, VA 23320

MADE IN CANADA

ASSURED™

Compare to ACT® active ingredient*

Kids Anticavity

Fluoride Rinse
BUBBLEGUM

ALCOHOL FREE

CAVITY PROTECTION
18 FL. OZ. (532 mL)

Kids Anticavity Fluoride Rinse

ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE (UNII: SE337SVY37)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
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 DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0015-7532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2010
Labeler - Greenbrier International, Inc. (610322518)

Revised: 8/2021
Document Id: ca3f18b5-792b-1077-e053-2a95a90a6ca0
Set id: 8802c26b-47e2-cb92-e053-2995a90a63da
Version: 3
Effective Time: 20210823
 
Greenbrier International, Inc.