DICLOFENAC SODIUM- diclofenac sodium topical gel, 1% gel 
Proficient Rx LP

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

Active ingredient

Diclofenac sodium (NSAID*) 1%
*nonsteroidal anti‑inflammatory drug

Inactive ingredients

Inactive ingredients:

Carbomer Homopolymer Type C, Coco-Caprylate/caprate, Isopropyl Alcohol, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Purified Water, Strong Ammonia Solution

Purpose

Arthritis pain reliever

Uses

for the temporary relief of arthritis pain ONLY in the following areas:
o
hand, wrist, elbow (upper body areas)
o
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 non-prescription 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
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.

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, 1% Arthritis Pain. The dosing card is re-usable.

Other information

Store at 20-25oC (68°F - 77°F). Keep from freezing.
read all product information before using. Keep the dossing card, the carton and accompanying User guide for important information.

Inactive ingredients

Carbomer homopolymer Type C, cocoyl caprylocaprate, ispropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.

Question and comments 1-833-285-4151

PRINCIPAL DISPLAY PANEL


Carton Label - NDC 71205-747-00

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For external use only

For daily Treatment of Arthritis Pain Anti-Inflammatory

Net Wt 3.53 OZ (100 g)

71205-747-00



Container Label

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For external use only

For daily Treatment of Arthritis Pain Anti-Inflammatory

Net Wt 3.53 OZ (100 g)

Dosing Card
Use Enclosed Dosing Card to Measure a Dose

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 your doctor

DICLOFENAC SODIUM 
diclofenac sodium topical gel, 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-747(NDC:43598-977)
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 (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
COCOYL CAPRYLOCAPRATE (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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-747-001 in 1 CARTON01/18/2023
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21098609/14/2020
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(71205-747)

Revised: 1/2023
Document Id: b4694451-a13d-484e-92c4-c03a6fcbb511
Set id: b4694451-a13d-484e-92c4-c03a6fcbb511
Version: 1
Effective Time: 20230101
 
Proficient Rx LP