Label: ALEVE ARTHRITIS PAIN GEL- diclofenac sodium gel

  • NDC Code(s): 0280-0039-01, 0280-0039-02
  • Packager: Bayer HealthCare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 26, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

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

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Arthritis pain reliever

  • Uses

    • for temporary relief 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 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 18 years.

    Ask a doctor or pharmacist before use

    • 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 (1-800-222-1222).

  • 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.

    DailyPer 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 (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 for longer than directed
    • apply to only clean, dry skin that does not have cuts, open wounds, infections or rashes
    • do not apply in the same area as any other product
    • do not apply with external heat such as heating pad
    • do not apply to bandage over the treated area
    • store ENCLOSED DOSING CARD with your ALEVE Arthritis Pain. The dosing cards 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 HOMOPOLYER TYPE C, COCOYL CAPRYLOCAPRATE, FRAGRANCE, ISOPROPYL ALCOHOL; MINERAL OIL; POLYOXYL 20 CETOSTEARYL ETHER; PROPYLENE GLYCOL, PURIFIED WATER, STRONG AMONIA SOLUTION

  • QUESTIONS

    Questions or Comments 1-800-395-0689

  • PRINCIPAL DISPLAY PANEL

    NEW!

    DIFFERENT

    INGREDIENT

    DICLOFENAC

    SODIUM

    ALEVE® ARTHRITIS

    PAIN GEL

    Diclofenac Sodium Topical Gel 1% (NSAID)

    Arthritis Pain Reliever

    FOR DAILY

    TREATMENT OF

    ARTHRITIS PAIN

    ANTI-INFLAMMATORY

    FOR EXTERNAL USE ONLY

    NET WT 3.53 OZ (100 g)

    Carton label AleveX Pain Gel

  • INGREDIENTS AND APPEARANCE
    ALEVE ARTHRITIS PAIN GEL 
    diclofenac sodium gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    AMMONIA (UNII: 5138Q19F1X)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0039-011 in 1 CARTON06/01/2021
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0280-0039-021 in 1 CARTON06/01/2021
    250 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21125306/01/2021
    Labeler - Bayer HealthCare LLC (112117283)