ANTICAVITY- sodium fluoride rinse

Anticavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

Disclaimer

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

This TOPCARE product is laboratory tested to guarantee its highest quality.  Your total satisfaction is guaranteed.

Adverse reactions section

DISTRIBUTED BY TOPCO ASOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139 TOPCO

topcare@topco.com

9871.000/971AA

principal display panel

Sealed With Printed Neckband For Your Protection

TOPCARE

FRESH MINT

Fluoride

Anit-Cavity

Mouth Rinse

Sodium Fluoride and Acidulated Phosphate Topical Solution

• Alcohol Free
• Kills bad breath germs
• Restores enamel
• Cleans the entire mouth

COMPARE TO LISTERINE Total Care Zero Anticavity Mouthwash

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ) (1 L)

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-971
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: 36800-971-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/19/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/19/2013

Labeler - TOPCO Associates LLC (006935977)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(36800-971)