Label: VOLTAREN ARTHRITIS PAIN- diclofenac sodium gel
VOLTAREN ARTHRITIS PAIN- diclofenac sodium kit

  • NDC Code(s): 0067-8152-01, 0067-8152-02, 0067-8152-03, 0067-8152-04, view more
    0067-8152-05, 0067-8153-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 14, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient

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

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Arthritis pain reliever

  • Uses

    for the temporary treatment of arthritis pain ONLY in the following areas:
    hand, wrist, elbow (upper body areas)
    foot, 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:
    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 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.

    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?

    1-855-297-3031

    www.voltarengel.com

  • SPL UNCLASSIFIED SECTION

    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)

  • Principal Display Panel

    NDC 0067-8152-04

    Voltaren

    ARTHRITIS PAIN

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

    NEW

    ORIGINAL PRESCRIPTION STRENGTH

    For Daily Treatment of Arthritis Pain

    Anti-Inflammatory

    NET WT 5.29 oz (150 g)

    For external use only

    Made in Canada

    Distributed by: GSK Consumer Healthcare, Warren NJ 07059

    Trademarks owned or licensed by GSK.

    ©2019 GSK or licensor.

    62000000036646

    Voltaren Arthritis Pain 150g carton
  • Principal Display Panel

    NDC 0067-8153-01

    Voltaren

    ARTHRITIS PAIN

    diclofenac sodium topical gel, 1% (NSAID) • arthritis pain relieving

    NEW

    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

    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)

    Made in Canada

    Distributed by: GSK Consumer Healthcare, Warren NJ 07059

    Trademarks owned or licensed by GSK.

    ©2019 GSK or licensor.

    1000224

    Voltaren Arthritis Pain 350g backercard
  • INGREDIENTS AND APPEARANCE
    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
    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 - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmanalytica SA487967499ANALYSIS(0067-8152, 0067-8153)