VOLTAREN  ARTHRITIS PAIN- diclofenac sodium gel 
VOLTAREN  ARTHRITIS PAIN- diclofenac sodium 
Haleon US Holdings LLC

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Drug Facts

Active ingredient

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

*nonsteroidal anti-inflammatory drug

Purpose

Arthritis pain reliever

Uses

Warnings

For external use only

Allergy alert:Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

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

Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you

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:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have 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 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 Guidefor complete instructions:

Other 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 www.voltarengel.com

Additional Information

ORIGINAL PRESCRIPTION STRENGTH

Medicated Gel Clinically Proven to Relieve Arthritis Pain

TREATMENT AREAS

TREATMENT AREAS

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 dose2.25 inches long (2 grams)

Lower body dose4.5 inches long (4 grams)

How to Use

Principal Display Panel

NDC 0067-8152-02

Voltaren

ARTHRITIS PAIN

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

Anti-Inflammatory

For Daily Treatment of Arthritis Pain

For external use only

NET WT 1.76 oz (50 g)

1-855-297-3031

Made in Canada

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Trademarks owned or licensed by GSK.

©2021 GSK or licensor.

30000000000042 Front Carton

Voltaren Arthritis Pain 1.76 oz (50 g)

Principal Display Panel

ORIGINAL PRESCRIPTION STRENGTH

Voltaren

ARTHRITIS PAIN

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

ANTI-INFLAMMATORY

For Daily Treatment of Arthritis Pain

Medicated Gel Clinically Proven to Relieve Arthritis Pain

NEW FLIP TOP CAP*

*Cap for 150 g only

For external use only

TREATMENT AREAS

204419 Voltaren Arthritis Pain 350g (12.34 oz) backercard
VOLTAREN   ARTHRITIS PAIN
diclofenac sodium gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8152-011 in 1 CARTON05/13/2020
120 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
2NDC:0067-8152-021 in 1 CARTON05/13/2020
250 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
3NDC:0067-8152-031 in 1 CARTON05/13/2020
3100 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
4NDC:0067-8152-041 in 1 CARTON05/13/2020
4150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
5NDC:0067-8152-053 in 1 CARTON09/01/202009/02/2020
5150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
6NDC:0067-8152-082 in 1 CARTON05/31/2021
6100 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:0067-8152-091 in 1 CARTON05/31/2021
720 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02212205/13/2020
VOLTAREN   ARTHRITIS PAIN
diclofenac sodium kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8153
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8153-011 in 1 CARTON; Type 0: Not a Combination Product05/13/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 TUBE 300 g
Part 21 TUBE 50 g
Part 1 of 2
VOLTAREN   ARTHRITIS PAIN
diclofenac sodium gel
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 KIT
1150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02212205/13/2020
Part 2 of 2
VOLTAREN   ARTHRITIS PAIN
diclofenac sodium gel
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 KIT
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02212205/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02212205/13/2020
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 138b29f0-acb3-e32f-e063-6394a90a3b90
Set id: 30a94282-0892-442a-aa10-6525cbd4fe88
Version: 12
Effective Time: 20240313
 
Haleon US Holdings LLC