Triflora

Manufacturer
Schwabe North America, Inc | Schwabe Mexico SA DE CV
Effective date
2025-11-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:35:13

Label at a glance#

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

Dosage and administration

Directions Adults and children 6 years of age and older: apply to affected area up to 4 times daily; rub in gently. Patch test recommended on sensitive skin.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Contains 5% Ledum palustre 2X

Contains 12.5% Urtica diocia 1X

Contains 2.5% Rhus tox 4X

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Carbomer

Ethyl Alcohol

Pine Needle Oil

Purified Water

Sodium Hydroxide

Witch Hazel Distillate

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 6 years of age and older: apply to affected area up to 4 times daily; rub in gently.

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.

Warnings

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 Poison Ivy (Rhus tox) or any other ingredient in this product.

Breast-feeding women should not apply to breast area. 

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 signs 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 right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LHBN21825297_B01_TRIFLORA_2_75OZ_CTN_FNL.jpgLHBN21825297_B01_TRIFLORA_2_75OZ_CTN_FNL.jpg

LHT21825297_B01_Triflora_2_75oz_Tube_FNL.jpgLHT21825297_B01_Triflora_2_75oz_Tube_FNL.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130308078252971GTIN-13: 0308078252971
EAN-13: 0308078252971
GTIN-12: 308078252971
UPC-A: 308078252971
GTIN storage (14 digits): 00308078252971
LHBN21825297_B01_TRIFLORA_2_75OZ_CTN_FNL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-7290-4Triflora1 in 1 CARTONGEL15
53499-7290-4Triflora28 g in 1 TUBEGEL285
53499-7290-8Triflora77 g in 1 TUBEGEL775
53499-7290-8Triflora1 in 1 CARTONGEL15

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
53499-729053499-7290-8, 53499-7290-4

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
TrifloraURTICA DOICIA, RHUS TOXICODENDRON, LEDUM PALUSTRESchwabe North America, Inc0f7796ae-a20e-431f-bdec-bca7415b468f2025-11-18WarningsExact identifier
ndc (package): 53499-7290-4
ndc (package): 53499-7290-8
ndc (product): 53499-7290
ndc11 (package): 53499729004
ndc11 (package): 53499729008
spl id: be615942-cb86-4d3d-8177-efc815ac4ff8
spl set id: 0f7796ae-a20e-431f-bdec-bca7415b468f

Reported adverse events (FAERS/openFDA)#

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