Voltaren Kit
FDA Label NDC 0067-8154

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Voltaren (NDC 0067-8154). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children., uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Diclofenac sodium 1% (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Arthritis pain reliever

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

  • for the treatment of arthritis pain ONLY in the following areas:
    • ohand, wrist, elbow (upper body areas)
    • ofoot, ankle, knee (lower body areas)
    • this product may take up to 7 days to work for arthritis pain; it is not for immediate relief

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) • skin reddening • blisters

    • • facial swelling • shock • rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    Liver warning: This product contains diclofenac. Liver damage may occur if you apply

    • more or for a longer time than directed
    • when using other drugs containing diclofenac

      • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach

      • bleeding. The chance is small but higher if you
      • are age 60 or older
      • have had stomach ulcers or bleeding problems
      • take a blood thinning (anticoagulant) or steroid drug
      • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
      • have 3 or more alcoholic drinks every day while using this product
      • apply more or for longer than directed

        • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • for strains, sprains, bruises or sports injuries
  • right before or after heart surgery
  • on more than 2 body areas at the same time
  • in the eyes, nose or mouth

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
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic

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 This Product

  • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 21 days
  • redness or swelling is present in the painful area
  • fever occurs
  • skin irritation occurs
  • any new symptoms appear
  • you experience any of the following signs of stomach bleeding:
    • ofeel faint
    • ohave bloody or black stools
    • ovomit blood
    • ohave stomach pain that does not get better
    • you have symptoms of heart problems or stroke:
    •  • chest pain • trouble breathing • leg swelling • weakness in one part or side of body
    • slurred speech

If Pregnant Or Breast-Feeding,

ask a health professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Directions

Use up to 21 days unless directed by your doctor

• Use 4 times per day every day
  • • Do not use on more than 2 body areas at the same time• For each upper body area (hand, wrist, or elbow) –
  • Squeeze out 2.25 inches
  • (2 grams)
  • • For each lower body area
  • (foot, ankle or knee) –
  • Squeeze out 4.5 inches
  • (4 grams)

    Daily

    Per Dose

    For your arthritis pain:

      

    Use ENCLOSED DOSING CARD to measure a dose

           

    Read The Enclosed Consumer User Guide For Complete Instructions:

    • use only as directed
    • do not use more than directed or for longer than directed
    • apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes
    • do not apply in same area as any other product
    • do not apply with external heat such as heating pad
    • do not apply a bandage over the treated area

    Other Information

    • store at 20-25°C (68-77°F). Keep from freezing.
    • read all product information before using. Keep the dosing card, this box and accompanying leaflet for important information.

    Inactive Ingredients

    carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

    Questions Or Comments?

    1-855-297-3031

    Use Enclosed Dosing Card To Measure A Dose

    How to Use

    • ◻For arthritis pain only
    • ◻Use 4 times a day
    • ◻May take up to 7 days to work for your arthritis pain
    • ◻For use on no more than 2 body areas
    • ◻Use up to 21 days unless directed by your doctor

    Principal Display Panel

    NDC 0067-8152-02

    Voltaren

    ARTHRITIS PAIN

    NEW

    Diclofenac sodium 1% (NSAID) • Arthritis Pain Relieving Gel

    For Daily Treatment of Arthritis Pain

    Anti-Inflammatory

    FULL PRESCRIPTION STRENGTH

    TREATMENT AREAS

    Powerful Medicated Gel

    Clinically Proven to Treat Arthritis Pain

    Voltaren Emulgel TM

    •  Hand Wrist Elbow Foot Ankle Knee

      • Not for use on any other body area (such as back, hip, or shoulder)

      Non Greasy Gel

      Clean Scent

      NET WT 1.76 oz (50 g)

      Made in Canada

      Distributed by: GSK Consumer Healthcare, Warren NJ 07059

      Trademarks are owned by or licensed to the GSK group of companies.

      834884-50c_voltaren Arthritis Pain_50 G Carton.jpg (Image 01)

      834884-50c_voltaren Arthritis Pain_50 G Carton.jpg (Image 01)

      NDC 0067-8153-01

      Voltaren

      ARTHRITIS PAIN

      Diclofenac sodium 1% (NSAID) • Arthritis Pain Relieving Gel

      FULL PRESCRIPTION STRENGTH

      NEW

      Powerful Medicated Gel

      Clinically Proven to Treat Arthritis Pain

      Voltaren Emulgel TM

      • For Daily Treatment of Arthritis Pain
      • Anti-Inflammatory
      • Non Greasy Gel
      • Clean Scent

        • TREATMENT AREAS

        •  Hand Wrist Elbow Foot Ankle Knee

          • EASY TWIST CAP*

          Not for use on any other body area (such as back, hip, or shoulder)

          NET WT 2 x 150 g + 50 g (350 g)

          Made in Canada

          Distributed by: GSK Consumer Healthcare, Warren NJ 07059

          Trademarks are owned by or licensed to the GSK group of companies.

    * Please review the disclaimer below.