TRIFLORA- symphytum officinale, rhus toxicodendron, ledum palustre gel
schwabe north america

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Triflora

Active Ingredients (HPUS):

LEDUM PALUSTRE

RHUS TOXICODENDRON

SYMPHYTUM OFFICINALE

Inactive Ingredients:

CARBOMER HOMOPOLYMER TYPE C

ALCOHOL

PINE NEEDLE OIL (PINUS SYLVESTRIS)

WATER
SODIUM HYDROXIDE
WITCH HAZEL

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.

Warning:

For external use only. Avoid contact with eyes and broken skin.

This product contains poison ivy (Rhus toxicodendron) plant materials.

Do not use if hypersensitive to this or any other ingredients in this product.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Children:

Keep out of the reach of children.

Pregnancy or Breast Feeding:

Breast-feeding women should not apply to breast area.

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

Package Label and Principal Display:

TRIFLORA
symphytum officinale, rhus toxicodendron, ledum palustre gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53499-5290
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	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	1 [hp_X] in 78 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53499-5290-8	1 in 1 CARTON	01/01/2006	12/31/2020
1		78 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:53499-5290-4	1 in 1 CARTON	01/01/2006	12/31/2020
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2006	12/31/2020

Labeler - schwabe north america (831153908)

Name	Address	ID/FEI	Business Operations
Establishment
Schwabe Mexico SA DE CV		812805901	manufacture(53499-5290)

Revised: 4/2020

Document Id: 9f72c20b-7ca8-4d11-9372-13300b88ef18

Set id: ba6fec93-7e55-48d6-b94f-3c68b9ee9ac3

Version: 6

Effective Time: 20200424

schwabe north america