CaviRinse Sodium Fluoride Oral Rinse

Generic Name: sodium fluoride
Dosage Form: oral mouthwash

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

CaviRinse™
0.2% Sodium Fluoride Oral Rinse

DESCRIPTION:

CaviRinse oral rinse is a prescription formulation for use in the prevention of dental caries. This formulation contains 0.2% sodium fluoride in a neutral pH base to help prevent caries and enhance remineralization.

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ACTIVE INGREDIENT: Sodium Fluoride 0.2% w/v.

INACTIVE INGREDIENTS: Water, Glycerine, Microdent® (Ultramulsion® of dimethicone and poloxamer), sodium saccharin, flavoring, cetylpyridinum chloride.

CLINICAL PHARMACOLOGY:

The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. CaviRinse oral rinse provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges.

INDICATIONS AND USAGE:

CaviRinse oral rinse is indicated for use as part of a professional program for the prevention and control of dental caries. CaviRinse oral rinse should be swished vigorously between your teeth once weekly after brushing with conventional toothpaste, unless otherwise instructed by a dental professional.

CONTRAINDICATIONS:

Do not use in children less than 6 years of age unless recommended by a dental professional.

WARNINGS:

DO NOT SWALLOW. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.

ADVERSE REACTIONS:

Allergic reactions and other idiosyncrasies have been rarely reported.

OVERDOSAGE:

Medical attention should be sought if more than a standard dose is accidentally swallowed. A single 10ml application of CaviRinse oral rinse contains approximately 9mg of fluoride ion.

DOSAGE AND ADMINISTRATION:

Follow these instructions unless otherwise instructed by a dental professional. Use once weekly after brushing your teeth with a toothpaste. Pour 10ml of CaviRinse oral rinse into the dosage cup, vigorously swish between your teeth for one minute and then spit out. Children 6 to 16 years of age should thoroughly rinse mouth with water.

HOW SUPPLIED:

8oz (236.59ml) of rinse in a plastic bottle with dosage cup.

STORAGE: Do not freeze or expose to extreme heat.

Rx Only

Vanilla Mint Flavor – NDC 48878-3223-8

Made in U.S.A. by
3M ESPE
Dental Products
St. Paul, MN 55144-1000 U.S.A.
1-800-634-2249

CaviRinse is a trademark of 3M or 3M ESPE AG. MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.

© 3M 2010. All rights reserved.

Principal Display Panel – Carton Label

NDC 48878-3223-8

Mint

3M ESPE

CaviRinse

0.2 % Sodium Fluoride

Oral Rinse

Rx Only

Keep out of reach of children.

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

8 fl oz

(236.59ml)

Principal Display Panel – Bottle Label

NDC 48878-3223-8

Mint

3M ESPE

CaviRinse

0.2 % Sodium Fluoride

Oral Rinse

Rx Only

Keep out of reach of children.

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

8 fl oz

(236.59ml)

CAVIRINSE 
sodium fluoride mouthwash
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:48878-3223
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium fluoride (fluoride ion) sodium fluoride 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water  
glycerin  
saccharin sodium  
cetylpyridinium chloride anhydrous  
Packaging
# Item Code Package Description
1 NDC:48878-3223-8 1 BOTTLE (1 BOTTLE) in 1 BOX
1 236.59 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2005
Labeler - 3M ESPE Dental Products (799975909)
Establishment
Name Address ID/FEI Operations
3M ESPE Dental Products 799975909 MANUFACTURE
Revised: 08/2009
 
3M ESPE Dental Products



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