DICLOFENAC SODIUM- diclofenac sodium topical gel, 1% gel 
Simple Diagnostics

----------

Diclofenac Sodium Topical Gel, 1%



(NSAID) - arthritis pain reliever

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:

• 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

Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you

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 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 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 Guidefor complete instructions:

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, ispropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.

Question and comments 1-833-285-4151

Tube Label- 100g

Tube Label - 100 g

NDC 62379-401-01

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 (100g)

Tube Label - 100 g

Carton Label - 100 g

NDC 62379-401-02

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 (100g)

Carton Label - 100 g

Diclofenac Sodium Topical Gel, 1% - 150 gm

Net Wt 5.29 oz (150g)

Tube Label- 150 g

NDC 62379-401-03

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For external use only

For daily Treatment of Arthritis Pain Anti-Inflammatory

Tube Label - 150 g

Carton Label - 150 g

NDC 62379-401-04

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For daily Treatment of Arthritis Pain Anti-Inflammatory

Compare to the active ingredient in Voltaren Arthritis Pain Gel**

For external use only

For daily Treatment of Arthritis Pain Anti-Inflammatory

Carton Label- 150g

Dosing Card -Diclofenac Sodium Topical Gel, 1% (NSAID)- Arthritis pain reliever

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

Upper body dose 2.25 inches long (2 grams)

Lower body dose 4.5 inches long (4 grams)

Dosing Card

Read product User Guide before use Not for immediate pain relief

Dosing Card

DICLOFENAC SODIUM 
diclofenac sodium topical gel, 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62379-401
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 (UNII: 4Q93RCW27E)  
COCO-CAPRYLATE/CAPRATE (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:62379-401-021 in 1 CARTON03/13/2024
1NDC:62379-401-01100 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:62379-401-041 in 1 CARTON03/13/2024
2NDC:62379-401-03150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21098603/13/2024
Labeler - Simple Diagnostics (004135503)
Registrant - Simple Diagnostics (004135503)

Revised: 3/2024
Document Id: 14062028-4023-9b1c-e063-6394a90a1f53
Set id: 13925cd5-e121-80d2-e063-6394a90af9a9
Version: 8
Effective Time: 20240319
 
Simple Diagnostics