Diclofenac Sodium Gel

Manufacturer
Galloping LLC | Gabar Health Sciences Corp.
Effective date
2023-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:07

Label at a glance#

ProductDiclofenac Sodium Gel
Active ingredientDICLOFENAC
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Arthritis pain reliever

INDICATIONS & USAGE SECTION

•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 SECTION

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.

OTC - DO NOT USE SECTION

•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

OTC - ASK DOCTOR SECTION

•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.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

•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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Display PanelDisplay Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855633diclofenac sodium 1 % Topical GelPSN1
855633diclofenac sodium 0.01 MG/MG Topical GelSCD1
855633diclofenac sodium 1 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DICLOFENAC Pharmacologic Class Indexing2Indexing - Pharmacologic Class20190118

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83136-101-152025-01-30C16284748780-12cef2736-781c-d83d-e063-dadaa90ab31ffcc19814-4c19-a757-e053-6294a90a02d7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83136-101-15Diclofenac Sodium Gel150 g in 1 TUBEGEL1501
83136-101-15Diclofenac Sodium Gel1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83136-101DICLOFENAC SODIUM GEL GEL [GALLOPING LLC]12 package rows20230529_fcc19814-4c19-a757-e053-6294a90a02d7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83136-10183136-101-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fcc19814-4c1a-a757-e053-6294a90a02d7fcc19814-4c19-a757-e053-6294a90a02d72023-05-28WarningsExact identifier
spl id: fcc19814-4c1a-a757-e053-6294a90a02d7
spl set id: fcc19814-4c19-a757-e053-6294a90a02d7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.