ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid

Alcohol-Free Anticavity by

Drug Labeling and Warnings

Alcohol-Free Anticavity by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Vi-Jon, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

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, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

• use twice daily after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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

Inactive ingredients

water, glycerin, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

SPL UNCLASSIFIED SECTION

Oral Care

Alcohol free fluoride mouthwash 

Vivid mint

*This product is not manuractured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse.

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate burshing may prevent it occurence.

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

If you're not satisfied we'll happily refund your money.

Principal Display Panel

Sealed With Printed Neckband For Your Protection

RITE AID PHARMACY

Compare to the active ingredient in Crest Pro-Health Complete*

oral care

alcohol free fluoride mouthwash

anticavity fluoride rinse

vivid mint

multiple benefits in one rinse:

kills bad breath germs

helps prevent cavitites

helps strengthen enamel

cleans teeth

freshens breath 

use 2X daily for a healthier smile

IMPORTANT: read directions for proper use.

1 L (33.8 fl oz)

482.001/482AB

INGREDIENTS AND APPEARANCE

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-5567
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-5567-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/26/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/26/2013

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon, Inc. (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		790752542	manufacture(11822-5567)