Aleve Arthritis Pain Gel Ui 1614804

Aleve Arthritis Pain Gel Ui 1614804
SPL v5
SPL
SPL Set ID bad675d1-1204-0136-e053-2995a90a994e
Route
TOPICAL
Published
Effective Date 2021-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diclofenac (1 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Water Polyoxyl 20 Cetostearyl Ether Cocoyl Caprylocaprate Ammonia Isopropyl Alcohol Mineral Oil Propylene Glycol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-06-01

Description

Drug Facts


Medication Information

Warnings and Precautions

For external use only

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 51945-4

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)

Section 53413-1

Questions or Comments 1-800-395-0689

Section 53414-9

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.

Section 55105-1

Arthritis pain reliever

Section 55106-9

Active Ingredient

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

*nonsteroidal anti-inflammatory drug

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 (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.

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
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

When Using This Product
  • avoid contact with eyes, nose, or mouth
  • if eye contact occurs, rinse thoroughly with water
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.
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
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

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 and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

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)

Section 53413-1 (53413-1)

Questions or Comments 1-800-395-0689

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Arthritis pain reliever

Section 55106-9 (55106-9)

Active Ingredient

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

*nonsteroidal anti-inflammatory drug

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 (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.

Do Not Use (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
Other Information (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 (Inactive ingredients)

CARBOMER HOMOPOLYER TYPE C, COCOYL CAPRYLOCAPRATE, FRAGRANCE, ISOPROPYL ALCOHOL; MINERAL OIL; POLYOXYL 20 CETOSTEARYL ETHER; PROPYLENE GLYCOL, PURIFIED WATER, STRONG AMONIA SOLUTION

When Using This Product (When using this product)
  • avoid contact with eyes, nose, or mouth
  • if eye contact occurs, rinse thoroughly with water
Ask A Doctor Before Use If (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.
Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)
  • under a doctor's care for any serious condition
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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