Label: PHYTOGEL- homeopathic gel gel

  • 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 February 25, 2014

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    PhytoGel Label.jpg

  • Active Ingredients

    Arnica montana 1X–0.54%, Calendula officinalis 1X–0.54%, Hypericum perforatum 1X–0.54%, Arnica montana 30C, Bellis perennis 12X, Calcarea fluorica 30X, Ferrum phosphoricum 30X, Hypericum perforatum 30C, Ledum palustre 12X, Natrum sulphuricum 30C, Rhus toxicodendron 30X, Sulphuricum acidum 12X, Symphytum officinale 3X

  • Warnings Section

    If swallowed, get medical help or contact a Poison Control Center right away. For external use only. Do not apply to open wounds.

  • DO NOT USE

    Do not use if seal has been punctured or is not visible.

  • OVERDOSAGE

  • PREGNANCY OR BREAST FEEDING

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • STORAGE AND HANDLING

  • QUESTIONS

    Distributed by Energetix Corp.

    209 W. Deerfield Ln.

    Dahlonega, GA 30533

    800.990.7085

  • PURPOSE

    Topical, homeopathic pain-relief gel.

  • INACTIVE INGREDIENT

    Aloe barbadensis (Aloe Vera Gel), Water, Carbomer, [Potassium Sorbate, Phenoxyethanol (and) Ethylhexylglycerin, Sodium Hydroxide, each at 1% or less].

  • DOSAGE & ADMINISTRATION

    Apply topically three times daily or as directed by a healthcare professional.

  • INDICATIONS & USAGE

    Pain related to sprains, strains, bruises, joints, burns, sunburns, insect bites, skin irritations, and muscles aches.

  • INGREDIENTS AND APPEARANCE
    PHYTOGEL 
    homeopathic gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64578-0110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 59.1 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS12 [hp_X]  in 59.1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [hp_X]  in 59.1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 59.1 mL
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM30 [hp_X]  in 59.1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM1 [hp_X]  in 59.1 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG12 [hp_X]  in 59.1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE30 [hp_C]  in 59.1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 59.1 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID12 [hp_X]  in 59.1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 59.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 7.395801 mL  in 59.1 mL
    ALCOHOL (UNII: 3K9958V90M) 1.84895 mL  in 59.1 mL
    ALOE (UNII: V5VD430YW9) 46.494 g  in 59.1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64578-0110-159.1 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/14/2014
    Labeler - Energetix Corp (969572502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Terra Botanica LLC963736785manufacture(64578-0110) , label(64578-0110) , pack(64578-0110)