DICLOFENAC SODIUM- diclofenac sodium gel 
Advanced Rx Pharmacy of Tennessee, LLC

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Diclofenac Sodium 1% Gel

Active Ingredient

(NSAID) - arthritis pain reliever

Active ingredient

Diclofenac sodium (NSAID*) 1%

*nonsterodial anti-inflammatory drug

Purpose

Purpose

Arthritis pain reliever

Indications and Usage

Uses

– hand, wrist, elbow (upper body areas)

– foot, ankle, knee (lower body areas)

Warnings

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 contain an NSAID, which may cause severe stomach bleeding. The chance is small but high 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 attach, heart failure, and stroke. These can be fatal. The rish is higher if you use more than directed or for longer than directed.

Do Not Use

Do not use

Ask Doctor

Ask a doctor before use if

Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

When Using

When using this product

Stop Use

Stop use and ask a doctor if

Pregnancy or Breast Feeding

If pregnant or breast-feeding

ask a health care 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

Keep our of reach of children

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

Dosage & Administration

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 For arthritis pain:

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)

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 the 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 Safety Information

Other Information

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

Inactive Ingredients

Inactive ingredients

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

Questions and Comments

Questions and comments 1-866-747-7365

Principal Display Panel

label 1

DICLOFENAC SODIUM 
diclofenac sodium gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0233(NDC:70512-106)
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
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
AMMONIA (UNII: 5138Q19F1X)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80425-0233-11 in 1 CARTON02/06/2023
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21098602/06/2023
Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Establishment
NameAddressID/FEIBusiness Operations
Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0233)

Revised: 2/2023
Document Id: f3d27ae6-125a-5375-e053-2995a90a572d
Set id: f3d27ae6-1259-5375-e053-2995a90a572d
Version: 1
Effective Time: 20230203
 
Advanced Rx Pharmacy of Tennessee, LLC