ALEVE ARTHRITIS PAIN GEL- diclofenac sodium gel 
Bayer HealthCare LLC

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Aleve Arthritis Pain Gel UI 1614804

Drug Facts

Active Ingredient

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

*nonsteroidal anti-inflammatory drug

Arthritis pain reliever

Uses

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:

Other 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 or Comments 1-800-395-0689

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

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)

Revised: 11/2023
Document Id: 0b611f2d-bd72-258d-e063-6394a90af75b
Set id: bad675d1-1204-0136-e053-2995a90a994e
Version: 4
Effective Time: 20231130
 
Bayer HealthCare LLC