Label: ARTHRITIS PAIN RELIEVER- diclofenac sodium gel

  • NDC Code(s): 46122-752-37, 46122-752-52, 46122-752-53
  • Packager: AmerisourceBergen (Good Neighbor Pharmacy) 46122
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 9, 2023

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 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 the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years.

    Ask a doctor or pharmacist before use if

    • 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 of side of body
      • slurred speech

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important to not 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 (1-800-222-1222) 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 areas as any other product
    • do not apply with external heat such as a heating pad
    • do not apply a bandage over the treated area
    • store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.

  • Other information

    • store at 20° to 25°C (68° to 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?

    Call 1-877-753-3935 Monday-Friday 9 AM- 5 PM EST

  • Med Guide

    Use enclosed dosing card to measure a dose

    Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever

    [Upper body dose 2.25 inches long (2 grams)] Dosing Card (NOT ACTUAL SIZE)

    [Lower body dose 4.5 inches long (4 grams) Read product User Guide before use Not for immediate pain relief

    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 a doctor
  • Principal display panel

    Compare to Voltaren® Arthritis Pain Topical Gel active ingredient†

    Diclofenac Sodium Topical Gel, 1%

    (NSAID) Arthritis Pain Reliever

    Original prescription strength

    Medicated gel clinically proven to relieve arthritis pain

    For daily treatment of arthritis pain

    Anti-inflammatory

    For External Use only

    NET WT OZ (g)

    †This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Voltaren® Arthritis Pain Topical Gel.

    TAMPER EVIDENT STATEMENT: DO NOT USE IF FOIL SEAL ON TUBE OPENING IS BROKEN OR MISSING.

    Manufactured by:

    Amneal Pharmaceuticals LLC

    Piscataway, NJ 08854

    Distributed by: AmerisourceBergen

    1 West First Avenue, Conshohocken, PA 19428

  • Package Label

    Diclofenac Sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug

    GOOD NEIGHBOR PHARMACY Arthritis Pain Reliever

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEVER 
    diclofenac sodium gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-752
    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
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-752-531 in 1 CARTON04/01/2023
    1150 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:46122-752-371 in 1 CARTON04/01/2023
    250 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:46122-752-521 in 1 CARTON04/01/2023
    3100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20807704/01/2023
    Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)