Active ingredient

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

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

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 Anticavity Fluoride Rinse.

"SATISFACTION GUARANTEED OR YOUR MONEY BACK."

Manufactured for Your Military Exchanges

By: Vi-Jon 8515 Page Ave

St. Louis, MO 83114

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Compare to the active ingredient of Act Bubblegum Blowout Anticavity Kids Fluoride Rinse*

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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)

quality value

image description

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 - Military Exchanges (001695568)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(55301-004)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(55301-004)

Anticavity Fluoride Rinse, Bubble Gum004.002/004AE