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

  • NDC Code(s): 68466-2001-4, 68466-2001-8
  • Packager: Schwabe Mexico S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated March 27, 2023

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  • 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.

  • PRINCIPAL DISPLAY PANEL

    LBN21825297_B02_TRIFLORA_2_75OZ_CTN_FNL.jpg

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    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)
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