Diclofenac Sodium Gel
FDA Label NDC 68788-4335

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Diclofenac Sodium (NDC 68788-4335). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Other

→ Package Label-principal Display Panel - 1% W/w Tube Label (100 G Tube)

Drug Facts

Active ingredient
Diclofenac sodium USP (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:
- ohand, wrist, elbow (upper body areas)
- ofoot, 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:
- ofeel faint
- ohave bloody or black stools
- ovomit blood
- ohave stomach pain that does not get better
- you have symptoms of heart problems or stroke:
  - ochest pain
  - otrouble breathing
  - oleg swelling
  - oweakness in one part or side of body
  - oslurred 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.

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 diclofenac sodium topical gel arthritis pain. 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 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/58039/2020

Other

DICLOFENAC SODIUM TOPICAL GEL, 1%
Arthritis Pain
NSAID – Arthritis Pain Reliever
User Guide

How to use diclofenac sodium topical gel arthritis pain, with answers to frequently asked questions

Quick Start
How to get started right away with diclofenac sodium topical gel arthritis pain

Understanding Diclofenac Sodium Topical Gel Arthritis Pain
Diclofenac sodium topical gel arthritis pain (diclofenac sodium topical gel, 1% (NSAID) - arthritis pain reliever) is an arthritis pain relief medication that you apply to your skin. It is intended to be used 4 times a day every day for up to 21 days.

Before You Use Diclofenac Sodium Topical Gel Arthritis Pain
Read the Drug Facts Label, which appears on the carton.

Figure 1 (Diclofenac Fig1)

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 arthritis pain.

The first time you use a tube of diclofenac sodium topical gel arthritis pain:
You will have either one of the caps shown below.
1. Take the cap off the tube.

Figure (Diclofenac Fig2)

2. Lift tab and pull to remove foil seal prior to use. Do not open the safety seal with the scissors or other sharp objects.

Figure (Diclofenac Fig3)

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

Figure (Diclofenac Fig4)

Using Diclofenac Sodium Topical Gel Arthritis Pain

How often to use diclofenac sodium topical gel arthritis pain
Use 4 times a day for best results.

For example:

Figure (Diclofenac Fig5)

Where to apply diclofenac sodium topical gel arthritis pain
Diclofenac sodium topical gel arthritis pain 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:

Figure (Diclofenac Fig6)

Measuring the correct amount using the dosing card

Figure (Diclofenac Fig7)

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).

Figure (Diclofenac Fig8)

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 1-855-274-4122 to get a free replacement.

Applying Diclofenac Sodium Topical Gel Arthritis Pain
Gently rub diclofenac sodium topical gel arthritis pain 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.

Figure (Diclofenac Fig9)

After You Use Diclofenac Sodium Topical Gel Arthritis Pain

Figure (Diclofenac Fig10)

Wash your hands after applying diclofenac sodium topical gel arthritis pain.
If the treated area is the hands wait up to 1 hour to wash the hands.

Figure (Diclofenac Fig11)

Wash the dosing card with water. Store dosing card with your diclofenac sodium topical gel arthritis pain and keep out of reach of children.

Figure (Diclofenac Fig12)

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.

Facts you need to know
Important information about diclofenac sodium topical gel arthritis pain

Do not use diclofenac sodium topical gel arthritis pain...

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
you are taking any other drug
you are pregnant or breast-feeding

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.

Warnings to consider before use…
Allergy alert
Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
asthma (wheezing)
skin reddening
rash
blisters
facial swelling
shock

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 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. This can be fatal. The risk is higher if you use more than directed or for longer than directed.

Follow these important guidelines when using diclofenac sodium topical gel arthritis pain...

use only as 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 used on the skin
do not apply with external heat such as heating pad
do not apply a bandage over the treated area
do not get gel in eyes, nose or mouth
store ENCLOSED DOSING CARD with your diclofenac sodium topical gel arthritis pain. The dosing card is re-usable.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop using diclofenac sodium topical gel arthritis pain 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:
- ofeel faint
- ohave bloody or black stools
- ovomit blood
- ohave stomach pain that does not get better
- you have symptoms of heart problems or stroke:
  - ochest pain
  - otrouble breathing
  - oleg swelling
  - oweakness in one part or side of body
  - oslurred speech

Package Label-Principal Display Panel - 1% W/W Tube Label (100 G Tube)

ORIGINAL PRESCRIPTION STRENGTH

Diclofenac Sodium                                    ††Compare to Voltaren® Arthritis Pain
Topical Gel, 1%                                                                          Active Ingredient

Arthritis Pain
NSAID - Arthritis Pain Reliever                      FOR EXTERNAL USE ONLY
Anti-Inflammatory                                                       Net Wt. 3.53 oz (100 g)

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-4135-1 100g Tube

Diclofenac Sodium 1% Topical Gel (Diclofenac Fig15)

* Please review the disclaimer below.

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