EQUATE ARTHRITIS PAIN- diclofenac sodium gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
Available from:
Wal-Mart Stores Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Arthritis pain reliever
Authorization status:
Abbreviated New Drug Application
Authorization number:
49035-262-01

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EQUATE ARTHRITIS PAIN- diclofenac sodium gel

Wal-Mart Stores Inc

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Wal-Mart Arthritis Pain Drug Facts

Active ingredient

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

*nonsteroidal anti-inflammatory drug

Purpose

Arthritis pain reliever

Uses

Warnings

For external use only

Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people

allergic to aspirin.

Symptoms may include:

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

Stomach bleeding warning: This product contains an NSAID, which may cause

severe stomach bleeding. The chance is small but higher if you

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.

hives

asthma (wheezing)

skin reddening

blisters

facial swelling

shock

rash

more or for a longer time than directed

when using other drugs containing diclofenac

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

Ask a doctor before us if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

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

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.

under a doctor’s care for any serious condition

taking any other drug

avoid contact with eyes, nose, or mouth

if eye contact occurs, rinse thoroughly with water

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.

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.

Daily

Per Dose

For your arthritis pain:

Use ENCLOSED DOSING CARD to measure a

dose

Read the enclosed User Guide for complete instructions:

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

Use 4 times per day every day

Do not use on more than 2

body areas at the same time

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)

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 Diclofenac Sodium Topical Gel, 1%

Other 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?

1-888-287-1915

Diclofenac Sodium Topical Gel, 1% (NSAID)

Arthritis Pain Reliever

User Guide

How to use Diclofenac Sodium Topical Gel, 1% with answers to frequently asked

questions

Quick Start

How to get started right away with Diclofenac Sodium

Topical Gel, 1%

Understanding Diclofenac Sodium Topical Gel, 1%

Diclofenac Sodium Topical Gel, 1% (NSAID) – arthritis pain reliever is an arthritis pain

relief medication that you apply to your skin.

Before You Use Diclofenac Sodium Topical Gel, 1%

Read the Drug Facts Label, which appears on the carton.

product. The dosing card is re-usable.

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.

Remove the dosing card from the inside of the carton. You should always use the

dosing card to measure out the correct dose of Diclofenac Sodium Topical Gel, 1%. The

first time you use a tube of Diclofenac Sodium Topical Gel, 1%:

The first time you use a tube of Diclofenac Sodium Topical Gel, 1%:

1. Take the cap off the tube.

2. Open the safety seal by firmly pressing the point on the top of the cap onto the seal

on the tube. Do not open the safety seal with scissors or other sharp objects.

3. After use, put the cap back on the end of the tube.

Using Diclofenac Sodium Topical Gel, 1%

How often to use Diclofenac Sodium Topical Gel, 1%

Use 4 times a day for best results.

For example:

Where to apply Diclofenac Sodium Topical Gel, 1%

Diclofenac Sodium Topical Gel, 1% can be used on up to 2 body areas from the following

list: a hand, a wrist, an elbow, a foot, an ankle, a knee. Do not use on more than 2 body

areas at once.

Some examples include:

Measuring the correct amount using the dosing card

For each upper body area (a hand, a wrist, or an elbow): Squeeze gel from the tube

equal to the length shown on the upper body section of the dosing card (2.25 inches).

For each lower body area (a foot, an ankle, or a knee): Squeeze gel from the tube

equal to the length shown on the lower body section of the dosing card (4.5 inches).

Lost Your Dosing Card? Don’t worry!

Call 1-800-719-9260 to get a free replacement.

Applying Diclofenac Sodium Topical Gel, 1%

Gently rub Diclofenac Sodium Topical Gel, 1% into the skin using your hand. Apply 4

times a day for best results. Do not use on more than 2 body areas at once.

Apply only to clean, dry skin that doesn’t have any cuts, open wounds, infections or

rashes. Do not apply in the same area as any other medicines or products that are

applied to the skin.

After You Use Diclofenac Sodium Topical Gel, 1%

Wash your hands after applying Diclofenac Sodium Topical Gel, 1%. If the treated area

is the hands wait up to 1 hour to wash the hands.

Wash the dosing card with water. Store dosing card with your Diclofenac Sodium

Topical Gel, 1% and keep out of reach of children.

Wait ten minutes before covering the treated areas with clothes or gloves.

Avoid:

showering or bathing for at least 1 hour after use

exposing the treated area to sunlight or artificial light (such as in tanning booths)

use in same area as other products applied to the skin

applying a bandage over the treated area

eye, nose, or mouth contact

if eye contact occurs, rinse thoroughly with water

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