Label: DICLOFENAC SODIUM- 3% diclofenac spray aerosol, metered

  • NDC Code(s): 69621-300-01
  • Packager: Shoreline Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated March 10, 2016

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  • GENERAL PRECAUTIONS

    Diclofenac sodium 3% spray

    Use as directed.

    Qty 118

    No refills

    Shoreline Pharmaceuticals, Inc.

    16530 Ventura Blvd, Suite 610

    Encino, CA 91436

    310.464.9170

    Rx 616194

    N Dr:

    Date

    Discard by

    For External Use Only

    Compounded by Shoreline Pharmaceuticals

    Toll Free: 877-817-1885

    You may report side effects to FDA at 1-800-FDA-1088

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  • NDC69621-300-10
  • INGREDIENTS AND APPEARANCE
    DICLOFENAC SODIUM 
    3% diclofenac spray aerosol, metered
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69621-300
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM 30 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69621-300-01 1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/07/2016
    Labeler - Shoreline Pharmaceuticals, Inc. (078542781)
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