Diclocaine

Manufacturer
Neptune Products
Effective date
2022-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:50:32

Label at a glance#

ProductDiclocaine
Active ingredientLIDOCAINE, DICLOFENAC SODIUM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each patch):

Diclofenac Sodium (NSAID) 1.25% Arthritis Pain Reliever

Lidocaine 4.5% Topical Anesthetic

OTC - PURPOSE SECTION

USES:

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

  • Muscle soreness
  • Strains
  • Sprains
  • Arthritis
  • Simple backache
  • Muscle stiffness
  • Bruises

WARNINGS SECTION

WARNINGS:

For external use only

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you:

  • Are age 60 or older
  • Have had stomach ulcers or bleeding problems
  • Take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)
  • Take a blood thinning (anticoagulant) or steroidal drug
  • Have three or more alcoholic drinks every day while using this product
  • Take more or for a longer time than directed

Do not use:

  • On the face or rashes
  • On wounds or damaged skin
  • In the eyes, mouth, or other mucous membranes
  • On genitals
  • With a heating pad
  • If allergic to any NSAID’s
  • Right before or after heart surgery
  • Any patch from a pouch that has been opened for 7 or more days

Ask a doctor before use if:

  • You are allergic to topical products
  • The stomach bleeding warning applies to you
  • You are taking a diuretic
  • You have high blood pressure, heart disease, or kidney disease
  • You are pregnant

When using this product:

  • Wash hands after applying or removing patch
  • Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water
  • The risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and consult your physician if:

  • Stomach pain or upset gets worse or lasts
  • Rash, irritation, or itching develops
  • You feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)
  • Condition worsens

If pregnant or breast feeding, ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy 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 put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.

DOSAGE & ADMINISTRATION SECTION

Adults, or children over the age of 12:

Apply patch to affected are 1 to 2 times daily or as directed

INDICATIONS & USAGE SECTION

INSTRUCTIONS FOR USE:

  • Clean and dry affected area
  • Open pouch and remove one patch
  • Remove protective film from patch
  • Apply one patch to the affected area of pain and leave in place for 8 to 12 hours
  • If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
  • Only use one patch at a time
  • Do not use more than 2 patches per day
  • Wash hands with soup and water after applying or removing patch
  • Reseal pouch containing unused patches immediately after each use

OTHER SAFETY INFORMATION

OTHER INFORMATION:

  • Some individuals may not experience pain relief until several minutes or hours after applying the patch
  • Store in a cool, dry place
  • Protect product from excessive moisture or sunlight
  • Store at 67-77 °F (19-25 °C)

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Aloe Vera Gel, Arnica Extract, Boswellia Extract, Dihydroxyaluminum Aminoacetate, Dimethyl Sulfone, Glycerol, Methylparaben, Polyacrylic Acid, Polysorbate 80, Sodium Polyacryate, Sorbitol, Vitamin E, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

diclocainediclocaine

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72594-109572594-1095-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
0c7bd3a5-4429-732e-e063-6394a90a5201ebfcf319-b3a5-caed-e053-2995a90abebf2023-12-14WarningsExact identifier
spl set id: ebfcf319-b3a5-caed-e053-2995a90abebf

Reported adverse events (FAERS/openFDA)#

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