Arthritis Pain Reliever

Manufacturer
LifeMD
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:47:55

Label at a glance#

ProductArthritis Pain Reliever
Active ingredientDICLOFENAC SODIUM
Label structure11 sections

Indications and uses

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

Dosage and 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  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 inc...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Arthritis Pain Reliever

Uses

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

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.

Do not use

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

Ask a doctor before use if

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 the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years.

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

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 of side of body
    • slurred speech

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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 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:

  • 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 areas as any other product
  • do not apply with external heat such as a heating pad
  • do not apply a bandage over the treated area
  • store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.

Other information

SPL UNCLASSIFIED SECTION

  • store at 20° to 25°C (68° to 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 ingredients

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

Questions or comments?

OTC - QUESTIONS SECTION

Call (800) 852- 1575 Monday - Friday 9am-6pm EST

Med Guide

SPL MEDGUIDE SECTION

Use enclosed dosing card to measure a dose

Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever

[Upper body dose 2.25 inches long (2 grams)] Dosing Card (NOT ACTUAL SIZE)

[Lower body dose 4.5 inches long (4 grams) Read product User Guide before use Not for immediate pain relief

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 a doctor

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Voltaren® Arthritis Pain Topical Gel

Arthritis Pain Reliever

(NSAID) - Diclofenac sodium topical gel, 1%

  •  Original prescription strength
  • Medicated gel clinically proven to relieve arthritis pain
  • For daily treatment of arthritis pain
  • Anti-inflammatory
  • For external use only

Net wt wt oz (g)

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Voltaren® Arthritis Pain Topical Gel.

TAMPER EVIDENT STATEMENT: DO NOT USE IF FOIL SEAL ON TUBE OPENING IS BROKEN OR MISSING.

Distributed by:

LifeMD

236 5th Ave, Suite 400

New York, NY 10001

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIFEMD Arthritis Pain Reliever
LIFEMD Arthritis Pain Reliever

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82649-012ARTHRITIS PAIN RELIEVER (DICLOFENAC SODIUM) GEL [LIFEMD]2Legacy NDC20241204_30531101-e2f3-4a4c-b2ea-d8fcadbc9bf8.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82649-01282649-012-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208077-001DICLOFENAC SODIUMDICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-1884e616aacf4f…
2026-08-18 06:07:402026-07A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICALAB2016-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICALAB2016-03-183f01610625f2…
2019-09-15 20:21 UTC2019-09A208077-001DICLOFENAC SODIUM1%GEL / TOPICALAB2016-03-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A208077-001DICLOFENAC SODIUM1%GEL / TOPICALAB2016-03-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A208077-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A208077-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208077-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208077-001AB1ea99ee380514…

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
bd82d919-8921-4eb7-ae1c-b4d165acd3f730531101-e2f3-4a4c-b2ea-d8fcadbc9bf82024-12-02WarningsExact identifier
spl id: bd82d919-8921-4eb7-ae1c-b4d165acd3f7
spl set id: 30531101-e2f3-4a4c-b2ea-d8fcadbc9bf8

Reported adverse events (FAERS/openFDA)#

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