TRIFLORA- urtica doicia, rhus toxicodendron, ledum palustre gel

Triflora by

Drug Labeling and Warnings

Triflora by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc, Schwabe Mexico SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

URTICA DIOICA 1X

LEDUM PALUSTRE 2X

RHUS TOX 3X  

Inactive Ingredients:

Polyacrylic acid

ETHYL ALCOHOL

PINE NEEDLE OIL 

PURIFIED WATER
SODIUM HYDROXIDE
WITCH HAZEL DISTILLATE

DOSAGE & ADMINISTRATION

Dosage and Administration:

Boericke and Tafel Brand:

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 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

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.

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 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 
urtica doicia, rhus toxicodendron, ledum palustre gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-6290
Route of Administration	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: 53499-6290-8	1 in 1 CARTON	12/17/2018
1		78 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 53499-6290-4	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 North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico SA DE CV		812805901	manufacture(53499-6290)