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 INGREDIENT

Active Ingredients:

URTICA DIOICA 1X

LEDUM PALUSTRE 2X

RHUS TOX 3X

INACTIVE INGREDIENT

Inactive Ingredients:

Polyaryllic acid

ETHYL ALCOHOL

PINE NEEDLE OIL 

PURIFIED WATER
SODIUM HYDROXIDE
WITCH HAZEL DISTILLATE

DOSAGE & ADMINISTRATION

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.

INDICATIONS & USAGE

Indications and Usage:

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

PURPOSE

Purpose:

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

WARNINGS

Warning:

For external use only.

Avoid contact with eyes and broken skin.

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 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.

KEEP OUT OF REACH OF CHILDREN

Children:

Keep out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

PREGNANCY OR BREAST FEEDING

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

ASK DOCTOR

Ask the Doctor:

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.

OVERDOSAGE

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

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: 68466-1001
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 78 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	3 [hp_X]  in 78 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	2 [hp_X]  in 78 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: 68466-1001-8	1 in 1 CARTON	12/17/2018
1		78 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68466-1001-4	1 in 1 CARTON	12/17/2018
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		12/17/2018

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(68466-1001)