FLUORIDE MOUTH RINSE ANTICAVITY- sodium fluoride mouthwash

Fluoride Mouth Rinse Anticavity by

Drug Labeling and Warnings

Fluoride Mouth Rinse Anticavity by is a Otc medication manufactured, distributed, or labeled by Target Corp., Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 toothpaste
• remove cap
• pour 10 milliliters (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 then spit it 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 childrenas 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

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

SPL UNCLASSIFIED SECTION

The ADA Council on Scientific Affairs Acceptance of up & up mint anticativity fluoride rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed

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

Dist. by Target Corp., Mpls., MN 55403

Made in U.S.A. with U.S. and foretign components

Shop Target.com

Guest Services 1-800-910-6874

213.002/213AE rev 2

Principal display panel

SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ANTICAVITY

fluoride mouthrinse

*Compare to Act Anticavity Fluoride Rinse

helps prevent cavities

helps strengthen teeth

freshens breath

up & up 

Mint Flavor

IMPORTANT: read directions for proper use

18 fl oz (532 mL)

INGREDIENTS AND APPEARANCE

FLUORIDE MOUTH RINSE ANTICAVITY 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-213
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-213-44	.532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/17/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/17/2010

Labeler - Target Corp. (006961700)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(11673-213)