DICLOFENAC SODIUM GEL gel

Diclofenac Sodium Gel by

Drug Labeling and Warnings

Diclofenac Sodium Gel by is a Otc medication manufactured, distributed, or labeled by Galloping LLC, Gabar Health Sciences Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)

*nonsteroidal anti-inflammatory drug

PURPOSE

Arthritis pain reliever

INDICATIONS & USAGE

for the temporary relief of arthritis pain ONLY in the following areas:
hand, wrist, elbow (upper body areas)
foot, ankle, knee (lower body 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

more or for a longer time than directed
when using other drugs containing diclofenac

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small 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 nonprescription 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 attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

if you have ever had an allergic reaction to any other pain reliever or to a fever reducer
for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.
right before or after heart surgery
on more than 2 body areas at the same time
in the eyes, nose or mouth

you have problems or serious side effects from taking pain relievers or fever reducers
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you are taking a diuretic
you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.

under a doctor’s care for any serious condition
taking any other drug

avoid contact with eyes, nose, or mouth
if eye contact occurs, rinse thoroughly with water

pain gets worse or lasts more than 21 days
redness or swelling is present in the painful area
fever occurs
skin irritation occurs
any new symptoms appear. These could be signs of a serious condition.
you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
you have symptoms of heart problems or stroke:
chest pain
trouble breathing
leg swelling
weakness in one part or side of body
slurred speech

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.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

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 your arthritis pain:

Use 4 times per day every day
Do not use on more than 2 body areas at the same time

Per Dose

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:

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 ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% product. The dosing card is re-usable.

OTHER SAFETY INFORMATION

store at 20-25°C (68-77°F). Keep from freezing.
read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.

INACTIVE INGREDIENT

carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DICLOFENAC SODIUM GEL 
diclofenac sodium gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83136-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DICLOFENAC (UNII: 144O8QL0L1) (DICLOFENAC - UNII:144O8QL0L1)	DICLOFENAC	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83136-101-15	1 in 1 CARTON	05/28/2023
1		150 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211253	05/28/2023

Labeler - Galloping LLC (118849262)

Establishment
Name	Address	ID/FEI	Business Operations
Gabar Health Sciences Corp.		118401847	manufacture(83136-101)