DICLOFENAC SODIUM- diclofenac sodium topical gel, 1% gel 
Encube Ethicals Private Limited

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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 Guide for 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

Diclofenac Sodium Topical Gel, 1% -20 gm

Carton Label - 20 g

NDC 21922-044-25

ORIGINAL PRESCRIPTION STRENGTH

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

Net Wt 0.7 oz (20g)

Carton Label - 20 gm

Container Label- 20 g

NDC 21922-044-25

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For external use only

Net Wt 0.7 oz (20g)

Tube Label -20 gm

Diclofenac Sodium Topical Gel, 1% -50 gm

Carton Label - 50 g

NDC 21922-044-14

ORIGINAL PRESCRIPTION STRENGTH

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

Net Wt 1.76 oz (50g)

Carton Label - 50 gm

Container Label- 50 g

NDC 21922-044-14

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For external use only

Net Wt 1.76 oz (50g)

Tube Label - 50 gm

Diclofenac Sodium Topical Gel, 1% -100 gm

Carton Label - 100 g

NDC 21922-044-09

ORIGINAL PRESCRIPTION STRENGTH

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

Net Wt 3.53 oz (100g)

Carton Label - 100 gm

Container Label- 100 g

NDC 21922-044-09

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For external use only

Net Wt 3.53 oz (100g)

Tube Label - 100 gm

Diclofenac Sodium Topical Gel, 1% - 150 gm

Carton Label - 150 g

NDC 21922-044-26

ORIGINAL PRESCRIPTION STRENGTH

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

Net Wt 5.29 oz (150g)

Carton Label - 150 gm

Container Label- 150 g

NDC 21922-044-26

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For external use only

Net Wt 5.29 oz (150g)

Tube  Label - 150 gm

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:21922-044
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:21922-044-251 in 1 CARTON01/10/2022
120 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:21922-044-141 in 1 CARTON01/10/2022
250 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:21922-044-091 in 1 CARTON01/10/2022
3100 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:21922-044-261 in 1 CARTON01/10/2022
4150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21098601/10/2022
Labeler - Encube Ethicals Private Limited (915834105)
Establishment
NameAddressID/FEIBusiness Operations
Encube Ethicals Private Limited725076298manufacture(21922-044) , analysis(21922-044) , pack(21922-044) , label(21922-044)

Revised: 1/2022
Document Id: d54f37ec-63f2-d2a7-e053-2995a90a2ffa
Set id: 6e8c45e1-8cd4-4ff7-a758-f9d2ed37e593
Version: 5
Effective Time: 20220111
 
Encube Ethicals Private Limited