Active Ingredients
Contains 5% Ledum palustre 2X
Contains 12.5% Urtica diocia 1X
Contains 2.5% Rhus tox 4X
Triflora Gel
FDA Label NDC 53499-7290
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc for the product Triflora (NDC 53499-7290). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, inactive ingredient, dosage and administration, indications & usage, purpose, warning, do not use, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Carbomer
ethyl alcohol
pine needle oil
purified water
sodium hydroxide
witch hazel distillate
Dosage And Administration
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
Temporarily relieves minor aches, pains, and joint/muscle stiffness associated with arthritis, rheumatism, simple backache and tendinitis.
Purpose
Temporarily relieves minor aches, pains, and joint/muscle stiffness associated with arthritis, rheumatism, simple backache and tendinitis.
Warning
For external use only.
Avoid contact with eyes and broken skin.
Do Not Use
Do not use if hypersensitive to Poison Ivy (Rhus tox) or any other ingredients in this product.
Breast-feeding women should not apply to breast area.
Stop Use
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
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose
If swallowed, seek medical help or contact a Poison Control Center immediately.
* Please review the disclaimer below.
