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Anticavity by TOPCO Associates LLC

Medically reviewed on Jun 6, 2018

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.02mg in 1mL
Labeler: TOPCO Associates LLC
NDC Code: 36800-971

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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)

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-971
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
SORBITOL 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
POLOXAMER 407 
SODIUM BENZOATE 
PHOSPHORIC ACID 
SACCHARIN SODIUM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
SUCRALOSE 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:36800-971-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/19/2013
Labeler - TOPCO Associates LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(36800-971)

 
TOPCO Associates LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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