Label: MOTRIN ARTHRITIS PAIN- diclofenac sodium gel

  • NDC Code(s): 50580-574-01, 50580-574-02
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 21, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

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

    *nonsteroidal anti-inammatory drug

  • Purpose

    Arthritis pain reliever

  • Uses

    • for the 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 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 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 (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.

    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 Motrin® Arthritis Pain product. 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, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

  • Questions or comments?

    Call 1-800-962-5357 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-574-02

    Original

    Prescription

    Strength

    New!

    Different Ingredient
    Diclofenac Sodium

    Motrin ®

    ARTHRITIS PAIN

    Diclofenac Sodium

    Topical Gel, 1% (NSAID)

    ARTHRITIS PAIN RELIEVER

    Anti-inflammatory

    For daily treatment of

    arthritis pain

    Fragrance

    Free**

    For external use only

    NET WT. 3.53 OZ (100 g)

    motrin-01

    USER GUIDE

    User Guide

  • INGREDIENTS AND APPEARANCE
    MOTRIN ARTHRITIS PAIN 
    diclofenac sodium gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-574
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM9.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    AMMONIA (UNII: 5138Q19F1X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-574-011 in 1 CARTON06/20/2022
    150 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:50580-574-021 in 1 CARTON06/20/2022
    2100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21125306/20/2022
    Labeler - Johnson & Johnson Consumer Inc. (878046358)