VoltarenArthritis Pain (diclofenac sodium) gel
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Voltaren
Arthritis Pain
diclofenac sodium
DICLOFENAC SODIUM
DICLOFENAC
AMMONIA
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
COCOYL CAPRYLOCAPRATE
ISOPROPYL ALCOHOL
MINERAL OIL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
WATER
Voltaren
Arthritis Pain
diclofenac sodium
Voltaren
Arthritis Pain
diclofenac sodium
DICLOFENAC SODIUM
DICLOFENAC
AMMONIA
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
COCOYL CAPRYLOCAPRATE
ISOPROPYL ALCOHOL
MINERAL OIL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
WATER
Voltaren
Arthritis Pain
diclofenac sodium
DICLOFENAC SODIUM
DICLOFENAC
AMMONIA
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
COCOYL CAPRYLOCAPRATE
ISOPROPYL ALCOHOL
MINERAL OIL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
WATER

Active ingredient

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)

*nonsteroidal anti-inflammatory drug

Purpose

Arthritis pain reliever

Uses

  • for the temporary relief 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. If no pain relief in 7 days, stop use.

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 or to a fever reducer
  • for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of 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
  • you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.

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, nose, or mouth
  • 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. These could be signs of a serious condition.
  • 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: ochest pain otrouble breathing oleg swelling oweakness in one part or side of body oslurred speech

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Per Dose

For your arthritis pain:

  •   Use 4 times per day every day
  •   Do not use on more than 2 body areas at the same time

Use ENCLOSED DOSING CARD to measure a dose

  •   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)

Read the enclosed 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
  • store ENCLOSED DOSING CARD with your Voltaren Arthritis Pain. The dosing card is re-usable.

Other information

  • store at 20-25°C (68-77°F). Keep from freezing.
  • read all product information before using. Keep the dosing card, this carton and accompanying User Guide 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?

1-855-297-3031www.voltarengel.com

Use Enclosed Dosing Card to Measure a Dose

Voltaren ARTHRITIS PAIN

diclofenac sodium topical gel, 1% (NSAID) – arthritis pain reliever

Dosing Card (NOT ACTUAL SIZE)

Read product User Guide before use

Not for immediate pain relief

Upper body dose 2.25 inches long (2 grams)

Lower body dose 4.5 inches long (4 grams)

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
  •   Tamper evident statement: Do not use if safety seal on tube nozzle is broken or missing.

Medicated Gel Clinically Proven to Relieve Arthritis Pain

TREATMENT AREAS

  •   Hand Wrist Elbow Foot Ankle Knee

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

EASY TWIST CAP

Principal Display Panel

NDC 0067-8152-03

Voltaren

ARTHRITIS PAIN

diclofenac sodium topical gel, 1% (NSAID) - arthritis pain reliever

ORIGINAL PRESCRIPTION STRENGTH

For Daily Treatment of Arthritis Pain

Anti-Inflammatory

NET WT 3.53 oz (100 g)

For external use only

1-855-297-3031

Made in Canada

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

©2021 GSK or licensor.

NPA004453

Voltaren Arthritis Pain 100g carton
Voltaren Arthritis Pain 100g carton

Principal Display Panel

NDC 0067-8153-01

Voltaren

ARTHRITIS PAIN

diclofenac sodium topical gel, 1% (NSAID) - arthritis pain reliever

ORIGINAL PRESCRIPTION STRENGTH

Medicated Gel Clinically Proven to Relieve Arthritis Pain

  • For Daily Treatment of Arthritis Pain
  • Anti-Inflammatory

TREATMENT AREAS

  •   Hand Wrist Elbow Foot Ankle Knee
  •  Not for use on any other body area (such as back, hip, or shoulder)

EASY TWIST CAP*

*Cap for 150 g only

For external use only

NET WT 2 X 150 g + 50 g (350 g) (12.34 oz)

1-855-297-3031

Made in Canada

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

©2021 GSK or licensor.

1000782

Voltaren Arthritis Pain 350g backercard
Voltaren Arthritis Pain 350g backercard