Label: TREE FROG- comfrey root, rosemary gel

  • NDC Code(s): 55715-007-01
  • Packager: Laboratorios Zepol S.A.
  • 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 1, 2023

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  • ACTIVE INGREDIENT

    Symphytum officinale extract 10X,

    Rosmarinus officinale extract 1X.

    For Purpose of

    Pain Relief

  • Other ingredients:

    Water, Carbomer, Phenoxyethanol (and) Caprylyl Glycol (and) Decylene Glycol, Eucalyptus globulus leaf oil, Gliceryn, Polysorbate 20, Color, Alcohol, Camphor, Menthol, Triethanolamine, Cinnamon aroma.

  • Directions:

    For minor aches and pains. External use only.

  • DOSAGE & ADMINISTRATION

    For best results, apply two to three times daily as needed.

  • WARNINGS SECTION

    Keep out of reach of children.

    Protect from heat. light and moisture. Do not use if safety seal is broken or missing. Do not use with a heating pad. Do not apply to cut, irritated or damaged skin. Do not use on face or near eyes.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    TREE FROG 
    comfrey root, rosemary gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55715-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT10 [hp_X]  in 1 mL
    ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9) ROSEMARY1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    ALCOHOL (UNII: 3K9958V90M)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CINNAMON (UNII: 5S29HWU6QB)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55715-007-01120 mL in 1 CONTAINER; Type 0: Not a Combination Product05/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/16/2023
    Labeler - Laboratorios Zepol S.A. (853070985)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Zepol S.A.853070985manufacture(55715-007)
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