DICLOFENAC SODIUM TOPICAL GEL 1%- diclofenac sodium topical gel, 1% gel 
Walgreens Company

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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

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 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:

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: 1-888-375-3784

PRINCIPAL DISPLAY PANEL


Carton Label - NDC 0363-7065-10


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 (100g)

Carton
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 (100g)


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 TOPICAL GEL 1% 
diclofenac sodium topical gel, 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7065
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:0363-7065-101 in 1 CARTON09/14/2020
1100 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0363-7065-202 in 1 CARTON04/09/2021
2100 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0363-7065-501 in 1 CARTON01/31/2021
350 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:0363-7065-151 in 1 CARTON01/31/2021
4150 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 - Walgreens Company (008965063)

Revised: 12/2020
Document Id: 25c889ad-9bfc-232a-3b29-a8fb3e9e556e
Set id: 40d0553b-a97a-1315-3fca-8ef38611505e
Version: 3
Effective Time: 20201216
 
Walgreens Company