Label: DICLOFENAC SODIUM- diclofenac sodium 1% gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 29, 2025

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  • ACTIVE INGREDIENT
    (NSAID) - arthritis pain reliever - Active ingredient - Diclofenac sodium (NSAID*) 1% *nonsterodial anti-inflammatory drug
  • PURPOSE
    Purpose - Arthritis pain reliever
  • INDICATIONS & USAGE
    Uses - for the temporary relief of arthritis pain - ONLYin the following areas: – hand, wrist, elbow (upper body areas) – foot, ankle, knee (lower body areas) This product may take up ...
  • WARNINGS
    Warnings - For external use only - Allergy alert:Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • asthma (wheezing) ...
  • DO NOT USE
    Do not use - if you have ever had an allergic reaction to any other pain reliever or to a fever reducer - for strains, sprains, bruises or sports injuries. This product has not been shown to work ...
  • ASK DOCTOR
    Ask a doctor before use if - you have problems or serious side effects from taking pain relievers or fever reducers - stomach bleeding warning applies to you or you have a history of stomach ...
  • ASK DOCTOR/PHARMACIST
    Ask a doctor or pharmacist before use if you are - under a doctor's care for any serious condition - taking any other drug
  • WHEN USING
    When using this product - avoid contact with eyes, nose, or mouth - if eye contact occurs, rinse thoroughly with water
  • STOP USE
    Stop use and ask a doctor if - pain gets worse or last more than 21 days - redness or swelling is present in the painful area - fever occurs - skin irritation occurs - any new symptoms appear. These could ...
  • PREGNANCY OR BREAST FEEDING
    If pregnant or breast-feeding - ask a health care professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do ...
  • KEEP OUT OF REACH OF CHILDREN
    Keep our of reach of children - If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION
    Directions - Use up to 21 days unless directed by your doctor - Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily For ...
  • OTHER SAFETY INFORMATION
    Other Information - Store at 20-25°C (68°F - 77°F). Keep from freezing. read all product information before using. Keep the dossing card, the carton and accomanying User guide for important ...
  • INACTIVE INGREDIENT
    Inactive ingredients - Carbomer homopolymer Type C, cocoyl caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia ...
  • QUESTIONS
    Questions and comments 1-866-747-7365
  • PRINCIPAL DISPLAY PANEL
    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    Product Information