Kids Flouride Rinse (Sodium Fluoride) Rinse [Army + Air Force Exchange Service] -

KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [ARMY + AIR FORCE EXCHANGE SERVICE]
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NDC	55301-004-44
Set ID	5f6f4125-6264-4724-bb7e-a6e100939b41
Category	HUMAN OTC DRUG LABEL
Packager	Army + Air Force Exchange Service
Generic Name
Product Class
Product Number
Application Number	PART355

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Active ingredient

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

Purpose

Anticavity rinse
Use

aids in the prevention of dental cavities
WARNINGS

Warnings

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 milliters (10 mL mark on inside of cap): do not fill above the 10 mL 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
Other information
- store at room temperature
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
Adverse reactions

*This is not manufactured or distributed by Chattem, Inc., distributor of Act

SATISFACTION GUARANTEED OR YOUR MONEY BACK
Manufactured for Your Military Exchanges
By: Vi-Jon
8515 Page Ave
St. Louis, MO 83114

004.002/004AE
principal display panel
Compare to the active ingredient of Act Bubblegum Blowout Anticavity Kids Fluoride Rinse

exchange select

KIDS

ANTICAVITY FLUORIDE RINSE

ALCOHOL FREE
- Strong cavity protection
- Helps strengthen teeth
Freshens Breath
BUBBLE GUM FLAVOR

IMPORTANT: read directions for proper use.

quality value

18 FL OZ (532 mL)

INGREDIENTS AND APPEARANCE

KIDS FLOURIDE RINSE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55301-004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55301-004-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/09/2011

Labeler - Army + Air Force Exchange Service (001695568)

Registrant - Vi-Jon, LLC (150931459)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		150931459	manufacture(55301-004)

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Medic

KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [ARMY + AIR FORCE EXCHANGE SERVICE]

Purpose

Keep out of reach of children.

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