Triflora

Manufacturer
Schwabe North America, Inc | Schwabe Mexico SA DE CV
Effective date
2021-10-01
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 22:34:24

Label at a glance#

ProductTriflora
Active ingredientURTICA DIOICA, TOXICODENDRON PUBESCENS LEAF, LEDUM PALUSTRE twig
Label structure11 sections

Dosage and administration

Directions: Adult and children 2 years of age and older: apply to affected area up to 4 times daily. Rub in gently. Children under 2 years of age: consult a doctor. Patch test recommended on sensitive skin.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

URTICA DIOICA 1X

LEDUM PALUSTRE 2X

RHUS TOX 3X  

Inactive Ingredient

INACTIVE INGREDIENT SECTION

PURIFIED WATER

ETHYL ALCOHOL

WITCH HAZEL DISTILLATE

POLYARLYLIC ACID

PINE NEEDLE OIL
SODIUM HYDROXIDE

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

Adult and children 2 years of age and older: apply to affected area up to 4 times daily.

Rub in gently.

Children under 2 years of age: consult a doctor.

Patch test recommended on sensitive skin.

Indications & Usage

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches, pains, and joint/muscle stiffness associated with arthritis, rheumatism, simple backache and tendinitis.

Purpose

OTC - PURPOSE SECTION

Temporarily relieves minor aches, pains, and joint/muscle stiffness associated with arthritis, rheumatism, simple backache and tendinitis.

Warning

WARNINGS SECTION

For external use only. 

Avoid contact with eyes and broken skin.

Do Not Use

OTC - DO NOT USE SECTION

Do not use if hypersensitive to this or any other ingredients in this product; this product contains poison ivy (Rhus tox) plant materials.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days.

These could be sigs of a serious condition.

Pregnancy or Breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

If swallowed, seek medical help or contact a Poison Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triflora Gel-218259290_A01.jpgTriflora Gel-218259290_A01.jpg

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
53499-629053499-6290-8, 53499-6290-4

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

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
7fd55ef8-9a5f-48eb-bc41-152d5e2a3aa97dd55ac1-e1d2-4404-9e33-2578aee719e32021-10-01WarningsExact identifier
spl id: 7fd55ef8-9a5f-48eb-bc41-152d5e2a3aa9
spl set id: 7dd55ac1-e1d2-4404-9e33-2578aee719e3

Reported adverse events (FAERS/openFDA)#

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