ANTICAVITY- sodium fluoride rinse

Anticavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

TEP

Sealed With Printed Neckband For Your Protection

Active Ingredients

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

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warning

for this product

Keep out of Reach of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

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 miute and 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

Other information

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

Inactive ingredients

water, sorbitol, propylene glycol, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, blue 1

Questions?

1-888-593-0593

Disclaimer

This product is not intended to replace brushing or flossing

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Zero Anticavity Mouthwash.

Adverse reactions section

Manufactured for Big Lots By Vi-Jon, Inc.

8515 Page Avenue

St. Louis, MO 63114

971.000/971AA

principal display panel

SOUNDBODY

Compare to the active

Ingredient in Listerine Total Care

Zero Anticavity Mouthwash

BURN FREE

Fluoride

Anti-Cavity

Mouthrinse

Sodium Fluoride and Acidulated Phosphate Topical Solution

Helps Strengthen Teeth to Fight Cavities

Helps Restore Enamel

Kill Bad Breath Germs

Freshens Breath

Cleans the Entire Mouth

Alcohol Free

IMPORTANT: read directions for proper use.

EUCALYPTUS MINT

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-971
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50594-971-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/19/2017

Labeler - Big Lots (017885351)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(50594-971)