ANTICAVITY- sodium fluoride rinse

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by UNIF, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

tep

Sealed with printed neckband for your protection

active ingredient

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

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warnings

For this product

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, see 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 10 mL mark
• vigorously swish 10 millilitrs of rinse between your teeth for 1 minute then spit out
• do not swallow the rinse
• do not eat or drink for 30 miutes 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 year of age: consult a dentist or doctor

Other information

• store at room temperture

inactive ingredient

benzyl alcohol, calcium disodium EDTA, cetylpyridiniun chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

ADA Council Statement

The ADA Council on Scientifc Affairs Acceptance of Equaline Kids Anticavity Fluoride Rine is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed.

disclaimer

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Bubblegum Blowout Anticavity Kids Fluoride Rinse.

Adverse Reaction 

DISTRIBUTED BY SUPERVALU INC.

EDEN PAIRIE, MN 55344 USA

Contacty us at 1-877-932-7948,

or www.supervalu-ourownbrands.com

principal display panel

Compare to Act Bubblegum

Blowout Anticavity Fluoride Rinse

active ingredent

EQUALINE

kids

anticavity

fluoride

rinse

ADA

Accepted

American

Dental

Association

• strong cavity protection
• helps strengthen teeth
• alcohol free

bubblegum flavor

IMPORTANT: READ DIRECTIONS FOR PROPER USE

18 FL OZ (532 mL)

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	10.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-004-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/17/2011

Labeler - Supervalu, Inc (006961411)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41163-004)