TRIFLORA GEL- urtica dioica, toxicodendron pubescens leaf, ledum palustre twig gel 
Schwabe Mexico S.A. de C.V.

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 Gel

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, in breast area when breast-feeding.

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.

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TRIFLORA GEL 
urtica dioica, toxicodendron pubescens leaf, ledum palustre twig gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68466-2001
Route of AdministrationTOPICAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA1 [hp_X]  in 77 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF4 [hp_X]  in 77 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG2 [hp_X]  in 77 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68466-2001-81 in 1 CARTON10/01/2021
177 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68466-2001-41 in 1 CARTON10/01/202109/30/2025
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/01/2021
Labeler - Schwabe Mexico S.A. de C.V. (812805901)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico S.A. de C.V.812805901manufacture(68466-2001)

Revised: 3/2023
Document Id: 3ab87f67-00b9-4995-9c3d-3263f075c7dc
Set id: a1c113ad-8c6c-4f19-b611-426e30f1db0e
Version: 3
Effective Time: 20230327
 
Schwabe Mexico S.A. de C.V.