Label: VOLTAREN ARTHRITIS PAIN- diclofenac sodium gel
VOLTAREN ARTHRITIS PAIN- diclofenac sodium kit
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NDC Code(s):
0067-8152-01,
0067-8152-02,
0067-8152-03,
0067-8152-04, view more0067-8152-05, 0067-8152-08, 0067-8152-09, 0067-8153-01
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 13, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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:
- 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
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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)
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Read the enclosed
User Guidefor 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
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Additional Information
ORIGINAL PRESCRIPTION STRENGTH
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)
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
- 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.
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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
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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
- Hand Wrist Elbow Foot Ankle Knee
- Not for use on any other body area (such as back, hip, or shoulder)
- Screw Cap Tamper evident statement: Do not use if safety seal on tube nozzle is broken or missing.
- Flip Cap Tamper evident statement: Do not use if plastic safety seals on sides of cap are broken or missing.
- 1-855-297-3031
- Made in India
- Distributed by: Haleon, Warren, NJ 07059
- Trademarks are owned by or licensed to the Haleon group of companies.
- @2023 Haleon group of companies or its licensor.
- 204419 Carton
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INGREDIENTS AND APPEARANCE
VOLTAREN ARTHRITIS PAIN
diclofenac sodium gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8152 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM 10 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8152-01 1 in 1 CARTON 05/13/2020 1 20 g in 1 TUBE; Type 1: Convenience Kit of Co-Package 2 NDC:0067-8152-02 1 in 1 CARTON 05/13/2020 2 50 g in 1 TUBE; Type 1: Convenience Kit of Co-Package 3 NDC:0067-8152-03 1 in 1 CARTON 05/13/2020 3 100 g in 1 TUBE; Type 1: Convenience Kit of Co-Package 4 NDC:0067-8152-04 1 in 1 CARTON 05/13/2020 4 150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package 5 NDC:0067-8152-05 3 in 1 CARTON 09/01/2020 09/02/2020 5 150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package 6 NDC:0067-8152-08 2 in 1 CARTON 05/31/2021 6 100 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:0067-8152-09 1 in 1 CARTON 05/31/2021 7 20 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022122 05/13/2020 VOLTAREN ARTHRITIS PAIN
diclofenac sodium kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8153 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8153-01 1 in 1 CARTON; Type 0: Not a Combination Product 05/13/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 TUBE 300 g Part 2 1 TUBE 50 g Part 1 of 2 VOLTAREN ARTHRITIS PAIN
diclofenac sodium gelProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM 10 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 KIT 1 150 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022122 05/13/2020 Part 2 of 2 VOLTAREN ARTHRITIS PAIN
diclofenac sodium gelProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM 10 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 KIT 1 50 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022122 05/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022122 05/13/2020 Labeler - Haleon US Holdings LLC (079944263)
