ANTICAVITY FLUORIDE RINSE- anticavity fluoride mouthwash

Anticavity Fluoride Rinse by

Drug Labeling and Warnings

Anticavity Fluoride Rinse by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Vi Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium ion 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, seek professional assistance or contact a Poison Control Center immediately.

DIRECTIONS

• adults and children 6 yeard of age and older: use once a day after brushing your teeth with a toothpaste
• remove cap
• pour 10 millilters (10 mL mark on inside of cap); do not fill above the 10 mL mark
• vigorously swish 10 millilters of rinse between your teeth for 1 minute and them 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 age: consult a dentist or doctor

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

Other information

store at room temperature

adverse reaction

DISTRIBUTE BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

SATISFACTION GUARANTEE

iF YOU ARE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY

PRINCIPAL DISPLAY PANEL

SHOPKO

COMPARE TO THE ACTIVE INGREDIENTS IN ACT

Kids

Anticavity

Fluoride

Rinse

Bubble Gum Flavor

Strong cavity protection

Helps strengthen teeth

Helps prevent cavities

Alcohol Free

IMPORTANT: read directions for proper use

18 FL OZ (532 mL)

INGREDIENTS AND APPEARANCE

ANTICAVITY FLUORIDE RINSE 
anticavity fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0004
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
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0004-1	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/08/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/08/2004

Labeler - Rite Aid (014578892)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(11822-0004)