FDA.reportPublic FDA data

Trifena

Manufacturer
Trifluent Pharma LLC
Effective date
2023-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:21:29

Label at a glance#

ProductTrifena
Active ingredientDICLOFENAC SODIUM, LIDOCAINE, MENTHOL, (+)-
Label structure9 sections

Indications and uses

For the temporary relief of pain.

Dosage and administration

Adults and Children 12 Years of Age and Older: Clean and dry to affected area Apply gel pad directly to your skin for up to 12 hours Using both hands remove the release film from one corner and apply the gel patch adhesive side to the skin affected area. Gel pad can be cut into pieces and used on up to 2 body parts at a time One application per day is recommended Wash hands immediately after use.

Storage and handling

Store at 59°F - 77°F with seal tightly sealed. If the tamper-evident foil seal is not intact, do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients
Diclofenac Sodium, USP 1.2%Arthritis Pain Reliever
Menthol, USP 5%Topical Analgesic
Lidocaine, USP 4%Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For External Use Only. Topical use only

Allergy Alert

SPL UNCLASSIFIED SECTION

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 see medical attention immediately.

Liver Warning

SPL UNCLASSIFIED SECTION

This product contains Diclofenac. Liver damage may occur if you apply

  • more or for a longer time than directed or
  • when using other drugs containing Diclofenac.

Stomach Bleeding Warning

SPL UNCLASSIFIED SECTION

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
  • Taking a blood thinning (anticoagulant) or steroid drug
  • Taking other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others)
  • Having 3 or more alcoholic drinks every day.
  • Applying more or for longer than directed.

Do Not Use

OTC - DO NOT USE SECTION

  • On damaged, irritated or infected skin
  • With a bandage or eating pad
  • If you are allergic to any ingredients in this product
  • Right before or after heart surgery
  • In the eyes, nose or mouth
  • Otherwise than directed.

When Using This Product

OTC - WHEN USING SECTION

Avoid contact with the eyes or mucous membranes

Stop Use and Ask a Doctor If

OTC - STOP USE SECTION

  • Any of the Warnings apply to you
  • You are taking a diurectic
  • You are taking any other drugs
  • You have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • Excessive skin irritation develops
  • Condition worsens
  • Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

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 directed by a doctor to do so.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested seek medical help or contact a Poison Control Center immediately

Flammable

SPL UNCLASSIFIED SECTION

Keep away from excessive heat or open flame

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 Years of Age and Older:

  • Clean and dry to affected area
  • Apply gel pad directly to your skin for up to 12 hours
  • Using both hands remove the release film from one corner and apply the gel patch adhesive side to the skin affected area.
  • Gel pad can be cut into pieces and used on up to 2 body parts at a time
  • One application per day is recommended
  • Wash hands immediately after use.

Other Information

STORAGE AND HANDLING SECTION

  • Store at 59°F - 77°F with seal tightly sealed.
  • If the tamper-evident foil seal is not intact, do not use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alpha Tocopherol Acetate, Aluminum Glycinate, Aluminium Hydroxide, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantion, Glycerine, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

Questions or Comments?

OTC - QUESTIONS SECTION

1-210-944-6920

PRINCIPAL DISPLAY PANEL - 15 Patch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 73352-565-01

15 PATCHES

trifena™

Pain Relief Patch

Diclofenac Sodium, USP 1.2%
Menthol, USP 5%
Lidocaine, USP 4%

TRIFLUENT
PHARMA®

PRINCIPAL DISPLAY PANEL - 15 Patch Carton
PRINCIPAL DISPLAY PANEL - 15 Patch Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-565-01EA - Each73352-5657cc0979d-648f-487a-a33b-c31c65c8a51412023-12-05

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73352-56573352-565-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICLOFENAC SODIUMQTG126297QACTIB
LIDOCAINE98PI200987ACTIB
MENTHOL, (+)-C6B1OE8P3WACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
SODIUM BORATE91MBZ8H3QOIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DMDM HYDANTOINBYR0546TOWIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE K90RDH86HJV5ZIACT

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
2032610f-2614-45f0-9c05-a3d5bfbb5357bbf08f2e-9afa-47e2-90ea-dafed11692d32024-12-31WarningsExact identifier
spl set id: bbf08f2e-9afa-47e2-90ea-dafed11692d3

Reported adverse events (FAERS/openFDA)#

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