Label: CAVIRINSE- sodium fluoride mouthwash

  • NDC Code(s): 48878-3223-8
  • Packager: 3M ESPE Dental Products
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/09

If you are a consumer or patient please visit this version.

  • 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.

    ACTIVE INGREDIENT: Sodium Fluoride 0.2% w/v.

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

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  • 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.

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  • 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.

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  • CONTRAINDICATIONS:

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

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  • 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.

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  • ADVERSE REACTIONS:

    Allergic reactions and other idiosyncrasies have been rarely reported.

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  • 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.

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  • 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.

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  • 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.

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  • 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 – Carton Label
    Close
  • 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)

    Principal Display Panel – Bottle Label
    Close
  • INGREDIENTS AND APPEARANCE
    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 Marketing Start Date Marketing End Date
    1 NDC:48878-3223-8 1 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 Business Operations
    3M ESPE Dental Products 799975909 MANUFACTURE
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