Triflora Gel
FDA Label NDC 68466-2001

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 Mexico S.a. De C.v. for the product Triflora Gel (NDC 68466-2001). 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 ingredients, dosage and administration, indications and usage, purpose, warning, do not use, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Contains 5% Ledium palustre 2X

Contains 12.5% Urtica doica 1X

Contains 2.5 Rhus tox 4X

Inactive Ingredients

Carbomer

Ethyl alcohol

Pine Need 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 And 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 Posion 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 signs of a serious condition

Pregnancy Or Breast Feeding

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

Keep Out Of Reach Of Children.

Keep out of reach of children.

Overdosage

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

* Please review the disclaimer below.