Dolo-NeuroBion

Manufacturer
BENARD INDUSTRIES INC
Effective date
2026-02-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-16 01:00:50

Label at a glance#

ProductDolo-NeuroBion Arthritis Pain
Active ingredientDICLOFENAC SODIUM
Label structure10 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...

Storage and handling

• 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.

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.

If pregnant or breast-feeding, 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 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%. The dosing card is re-usable.

Other information

STORAGE AND HANDLING SECTION

• 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 ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call (305) 594-0480

SPL UNCLASSIFIED SECTION

NEW

ORIGINAL PRESCRIPTION STRENGTH

USA

FOR DAILY TREATMENT OF ARTHRITIS PAIN / ANTI-INFLAMMATORY

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

Upper body dose 2.25 inches long (2 grams)
Lower body dose 4.5 inches long (4 grams)

Read product User Guide before use
Not for immediate pain relief

Tamper evident statement: Do not use if safety seal on tube nozzle is broken or missing.

Medicated Gel Clinically Proven to Relieve Arthritis Pain

TREATMENT AREAS
Hand
Wrist
Elbow
Foot
Ankle
Knee

Not for use on any other body area (such as back, hip or shoulder)

Distributed by: OTC Pharmaceutical Products
10860 NW 27th Street, Doral, FL 33172

www.otcpharmausa.com

MADE IN INDIA

To open tube: Unscrew cap and remove foil seal that covers the tube nozzle.

This tube does not contain full product information. Retain outer carton, dosing card, and User Guide for full product uses, directions and warnings.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dolo-NeuroBion Arthritis PainDolo-NeuroBion Arthritis Pain

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55959-12355959-123-50

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
A210986-001DICLOFENAC SODIUMDICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-2784e616aacf4f…
2026-08-18 06:07:402026-07A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-274b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27a50c72e98297…

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 14 · 273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsd9698809-4887-4514-aa28-0066355ef9082026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.5a852412-69af-6502-e063-6294a90a07482026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
DiclofenacDICLOFENAC SODIUMYYBA CORP533653e8-93d5-9080-e063-6394a90a165b2026-09-01WarningsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC5990259d-2f90-20d3-e063-6394a90a3d232026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
AMAZON BASIC CARE ARTHRITIS PAINDICLOFENAC SODIUMAmazon.com Services LLC113e2f87-c408-3e44-e063-6394a90a0a7f2026-08-20WarningsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC4dde6e36-7540-1cc3-e063-6294a90a39412026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMSportpharm LLCe9ec5462-939a-4022-8946-5d81869a62772026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)2a7019e9-e20f-4897-9b8e-942a7f2b34f62026-08-12WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.226da8a2-807d-4784-8d33-b434f3951a522026-08-12WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.681b6b25-4a28-44f2-8042-d5e01a5021162026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.57c83158-f072-6fa2-e063-6394a90aee2c2026-07-29WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.ddd2278b-70be-41ca-8a84-e3fe0f1a15612026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMCVS Pharmacy591cc2ed-e667-4779-a426-8a2e6f8735732026-07-22WarningsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMAurobindo Pharma Limitedd9b6f1d0-1710-46fb-8ea4-80b3ca60a5752026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMHAWAII REPACK, INCea113a58-c7ed-4768-9777-93d9b166dfbe2026-07-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAmerican Health Packaging63c00b50-06d3-4659-81cf-be4516429e812026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.6e6a6f98-5517-4f67-9a6a-71019ba2d7732026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.71a823c4-9c88-474d-b525-276f9e7808aa2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.09643e65-f301-4891-96f4-d78bf3621e232026-07-02WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.30c7e4fd-30af-4d28-a6ef-7386ff83cfb82026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM

Reported adverse events (FAERS/openFDA)#

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