TRIFLORA GEL- urtica dioica, toxicodendron pubescens leaf, ledum palustre twig gel

Triflora Gel by

Drug Labeling and Warnings

Triflora Gel by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe Mexico S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Needle Oil

Purified Water

Sodium Hydroxide

Witch Hazel Distillate

Dosage and Administration

Directions

Adult 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 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.

Warnings

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 right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIFLORA GEL 
urtica dioica, toxicodendron pubescens leaf, ledum palustre twig gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68466-2001
Route of Administration	TOPICAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46)	URTICA DIOICA	1 [hp_X]  in 77 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	4 [hp_X]  in 77 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	2 [hp_X]  in 77 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WITCH HAZEL (UNII: 101I4J0U34)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68466-2001-8	1 in 1 CARTON	10/01/2021
1		77 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68466-2001-4	1 in 1 CARTON	10/01/2021	09/30/2025
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/01/2021

Labeler - Schwabe Mexico S.A. de C.V. (812805901)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico S.A. de C.V.		812805901	manufacture(68466-2001)