Label: PHYTOGEL- arnica montana, calendula officinalis, hypericum perforatum, bellis perennis, calcarea fluorica, ferrum phosphoricum, ledum palustre, natrum sulphuricum, rhus tox, sulphuricum acidum, symphytum officinale 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 December 28, 2023

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  • ACTIVE INGREDIENT

    Active ingredients
    2 oz contains 1.638% of Arnica 30C, Bellis 12X, Calc fluor 30X, Ferrum phos 30X, Hypericum 30C, Ledum 12X, Nat sulphuricum 30C, Rhus
    tox 30X, Sulphuricum ac 12X, Symphytum 6X; 0.54% of Arnica 1X, Calendula 1X, Hypericum 1X.

    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INDICATIONS & USAGE

    Uses Temporary relief of pain related to sprains, strains, bruises, joints, burns, sunburns, insect bites, skin irritations, and muscle aches.

  • WARNINGS

    Warnings

    • If swallowed, get medical help or contact a Poison Control Center right away.
    • If pregnant or breast feeding, ask a health professional before use.
    • For external use only. Do not apply to open wounds.

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply topically three times daily or as directed by a healthcare professional.
    • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.
  • OTHER SAFETY INFORMATION

    Other information

    • Store at room temperature out of direct sunlight.
    • Do not use if tamper evident seal is broken or missing.
  • INACTIVE INGREDIENT

    Inactive ingredients Aloe Barbadensis (Aloe Vera) Leaf Juice, Purified Water, Ethanol, Carbomer, remaining ingredients at ≤ 1%: Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide.

  • QUESTIONS

    Distributed by Energetix Corp.
         Dahlonega, GA 30533
        Questions? Comments?
             800.990.7085
        www.energetix.com

  • PRINCIPAL DISPLAY PANEL

    energetix

    PhytoGel

    Topical, homeopathic

    pain-relief gel

    Pain related to sprains, strains,

    bruises, joints, burns,

    sunburns, insect bites, skin

    irritations, and muscle aches.

    Phytogel r08-22

    2 oz (56.7 g)

    Phytogel r08-22


    Purpose Temporary relief of pain related to sprains, strains, bruises, joints, burns, sunburns, insect bites, skin irritations, and muscle aches

  • INGREDIENTS AND APPEARANCE
    PHYTOGEL 
    arnica montana, calendula officinalis, hypericum perforatum, bellis perennis, calcarea fluorica, ferrum phosphoricum, ledum palustre, natrum sulphuricum, rhus tox, sulphuricum acidum, symphytum officinale gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64578-0127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM1 [hp_X]  in 1 g
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS12 [hp_X]  in 1 g
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [hp_X]  in 1 g
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM30 [hp_X]  in 1 g
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG12 [hp_X]  in 1 g
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE30 [hp_C]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 g
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID12 [hp_X]  in 1 g
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64578-0127-157 g in 1 TUBE; Type 0: Not a Combination Product06/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/15/2016
    Labeler - Energetix Corp (969572502)
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