DICLOFENAC SODIUM TOPICAL GEL, 1%- diclofenac sodium topical gel, 1% (nsaid) gel 
Mohnark Pharmaceuticals Inc.

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Diclofenac Sodium 1% Topical Arthritis Gel

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

for the temporary relief of arthritis pain ONLY in the following areas:

this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use

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.

For your arthritis pain:Daily Per Dose

Use 4 times per day every day
Do not use on more than 2 body

areas at the same time

Use DOSING GUIDE 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 (foor, ankle or knee) -

Squeeze out 4.5 inches (4 grams)

Read the entire directions on carton for 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 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 Diclofenac Sodium Gel with carton and dosing guide as shown.

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: 1-866-611-5206

INDICATIONS AND USAGE

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation.

Diclofenac is used to treat mild to moderate pain, or signs and symptoms of osteoarthritis or rheumatoid arthritis.

PRINCIPAL DISPLAY PANEL

Carton Label - NDC 73715-005-01

Diclofenac Sodium Topical Gel, 1%

(NSAID)- Arthritis pain reliever

For external use only

For daily Treatment of Arthritis Pain Anti-Inflammatory

Net Wt 1.76 oz (50g)

Container Label

DICLOFENAC SODIUM TOPICAL GEL, 1% 
diclofenac sodium topical gel, 1% (nsaid) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73715-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73715-005-0150 g in 1 CARTON; Type 0: Not a Combination Product08/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21098608/31/2021
Labeler - Mohnark Pharmaceuticals Inc. (117013830)
Registrant - Mohnark Pharmaceuticals Inc. (117013830)
Establishment
NameAddressID/FEIBusiness Operations
Mohnark Pharmaceuticals Inc117013830manufacture(73715-005)

Revised: 4/2021
Document Id: bfcb22d4-ff1a-2cdb-e053-2a95a90ada82
Set id: bfcb22d4-ff19-2cdb-e053-2a95a90ada82
Version: 1
Effective Time: 20210412
 
Mohnark Pharmaceuticals Inc.