Assured Anticavity Fluoride Kids Bubblegum (Sodium Fluoride) Rinse [Greenbrier International, Inc.] -

ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [GREENBRIER INTERNATIONAL, INC.]
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NDC	33992-0015-7
Set ID	8802c26b-47e2-cb92-e053-2995a90a63da
Category	HUMAN OTC DRUG LABEL
Packager	Greenbrier International, Inc.
Generic Name
Product Class
Product Number
Application Number	PART355

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active Ingredients

Sodium fluoride 0.05% (Fluoride ion-0.0226%)
PURPOSE

Purpose

Anticavity rinse
INDICATIONS & USAGE

Use aids in the prevention of dental cavities.
WARNINGS

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.
DOSAGE & ADMINISTRATION
Directions
- adults and children 6 years of age and older, use once a day after brushing your teeth with a toothpaste
- remove cap
- use approximately one tablespoon and rinse vigorously 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
- supervise children as necessary until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
INACTIVE INGREDIENT

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
SPL UNCLASSIFIED SECTION
Other information
- Store at room temperature
SPL UNCLASSIFIED SECTION

*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
PRINCIPAL DISPLAY PANEL

ASSURED™

Compare to ACT® active ingredient*

Kids Anticavity

Fluoride Rinse
BUBBLEGUM

ALCOHOL FREE

CAVITY PROTECTION
18 FL. OZ. (532 mL)

INGREDIENTS AND APPEARANCE

ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-0015
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-0015-7	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/01/2010

Labeler - Greenbrier International, Inc. (610322518)

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Medic

ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [GREENBRIER INTERNATIONAL, INC.]

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