ANTICAVITY- sdoium fluoride mouthwash

Anticavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Sodium fluoride 0.221%(0.021% w/v fluoride ion)

Purpose
Anticavity

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

Directions
Adults and children 12 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 and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
supervise children as necessary until capable of using without supervision
children under 12 years of age: consult a dents or doctor

STORAGE AND HANDLING

Other information
store at controlled room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰F)
cold weather may temporarily cloud this product

INACTIVE INGREDIENT

Inactive ingredients water, sorbitol solution; alcohol (21.6%), flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose and /or sodium saccharin,
diabasic sodium phosphate, D+C red no.33, FD+C blue no.1, FD+C yellow no.6

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine Total Care
DSP-TN-15000
DSP-MO-34
SDS-TN-15012

ADVERSE REACTIONS

DISTRIBUTED BY
ONPOINT, INC
2 PARAGON DRIVE
MONTVALE, NJ 07645

PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Live Better
Anticavity
Mouthwash
Sodium Fluoride and Acidulated
Phosphate Topical Solution
ICE MINT
Compare to Active Ingredients in Listerine Total Care
HELPS PREVENT CAVITIES
RESTORES ENAMEL
HELPS STRENGTHEN TEETH
HELPS KILL GERMS THAT CAUSE BAD BREATH
FRESHENS BREATH
IMPORTANT: READ DIRECTIONS FOR PROPER USE.
1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sdoium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51143-966
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	.0221 mL  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51143-966-86	1 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/21/2012

Labeler - Onpoint, Inc (001367366)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture