You are here: Home > Over-the-counter (OTC) Drugs > A > Anticavity Fluoride Rinse (Topco Associates Llc)

Name:Anticavity Fluoride Rinse
Manufacturer:Topco Associates Llc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTICAVITY FLUORIDE RINSE  - sodium fluoride rinse 
Topco Associates LLC

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 0.05% (0.02% w/v fluoride ion)

Purpose
Anticavity rinse

Use aids in the prevention of dental cavities

Warning

Enter section text here

Directions
• adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
• remove cap
• pour 10 milliters (10 mL mark on inside of cap): do not fill above the 10 mL mark 
• vigorously swish 10 milliliters 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 
• instruct children under 12 years of age in good rinsing habits ( to minimize swallowing)
• 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

Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride rinse.

Distributed by: TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
QUESTIONS? 1-888-423-0139

Children's
Alcohol Free
ANTIVACITY
FLUORIDE
RINSE
• Strong cavity protection
• Helps strengthen teeth
•  Helps prevent cavities
•  Freshens breath

COMPARE TO ACT active ingredient

IMPORTANT: READ
DIRECTIONS FOR PROPER USE

SEALED WITH PRINTED NECKBAND
FOR YOUR PROTECTION

18 FL OZ (532 mL)
image of principal display panel


ANTICAVITY FLUORIDE RINSE 
sodium fluoride rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-004
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .05 kg  in 100 L
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
CETYLPYRIDINIUM CHLORIDE  
POLOXAMER 407  
PROPYLENE GLYCOL  
SODIUM PHOSPHATE  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM (Bubble Gum Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-004-44 .5 L in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 04/08/2004

Labeler - Topco Associates LLC (006935977)
Registrant - Vi Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi Jon 790752542 manufacture

Revised: 10/2010 Topco Associates LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2020 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

OTC Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback