DICLOFENAC SODIUM- diclofenac sodium 1% gel 
SOLA Pharmaceuticals

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Diclofenac Sodium Gel 1%

(NSAID) - arthritis pain reliever

Active ingredient

Diclofenac sodium (NSAID*) 1%

*nonsterodial anti-inflammatory drug

Purpose

Arthritis pain reliever

Uses

– hand, wrist, elbow (upper body areas)

– foot, ankle, knee (lower body areas)

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

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

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 our 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 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 Information

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 1-866-747-7365

Principal Display Panel

Carton Label - 100g

NDC 70512-106-10

ORIGINAL PRESCRIPTION STRENGTH

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)

Diclofenac Carton

Tube Label- 100g

NDC 70512-106-10

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For external use only

Net Wt 3.53 oz (100 g)

Diclofenac Tube

DICLOFENAC SODIUM 
diclofenac sodium 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMMONIA (UNII: 5138Q19F1X)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70512-106-101 in 1 CARTON03/17/2021
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21098603/17/2021
Labeler - SOLA Pharmaceuticals (080121345)

Revised: 5/2024
Document Id: 18e5cdfa-1129-d694-e063-6394a90a01a9
Set id: bdbe3f24-3015-1f32-e053-2995a90aa665
Version: 5
Effective Time: 20240520
 
SOLA Pharmaceuticals