Label: TRAUMA FREE- symphytum officinale, bellis perennis, hypericum perforatum,, magnesia phosphorica, ruta graveolens, arnica montana, liquid

  • 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 August 3, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Symphytum officinale 3X, Bellis perennis, 12X, Hypericum perforatum 12X, Magnesia phosphorica 30X, Ruta graveolens 30X, Arnica montana 200X.

  • PURPOSE

    INDICATIONS:  For temporary relief of pain, swelling and bruising.


  • WARNINGS

    WARNING:  If pregnant or nursing, consult a health professional before use.  Keep cap closed tightly.  Do not store near computers or in temperature over 100 degrees.

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.  Do not use if tamper evident seal is broken or missing.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  For acute symptoms place 15 drops in mouth every 15-30 minutes for 2 hrs. then reduce to 2 to 4 times daily upon improvement.  Continue until symptoms are relieved.

    Children: 3-10 yrs. use 1/2 adult dose.  Avoid peppermint, spearmint, menthol or caffeine for at least 1 hr.  Remedies may be diluted in 1 tbsp. of pure water.  If symptoms worsen or persist for more than 7 days, consult a licensed practitioner.  Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, Ethanol 25%.


  • QUESTIONS


    Manufactured for:

    SAGO Natural Products

    110 E Main ave.

    Chewelah, WA 99109

    1-877-935-2633


  • PRINCIPAL DISPLAY PANEL

    TRAUMA FREE DROPS

    Homeopathic  

    2 fl. oz (60 ml)

    Trauma Free Drops

  • INGREDIENTS AND APPEARANCE
    TRAUMA FREE 
    symphytum officinale, bellis perennis, hypericum perforatum,, magnesia phosphorica, ruta graveolens, arnica montana, liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0265
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS12 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM12 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE30 [hp_X]  in 1 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP30 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA200 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0265-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/29/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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