Label: INJURY COMPOSITION- calendula officinalis, arnica montana, symphytum officinale, medulla ossis suis, belladonna, hamamelis virginiana, hypericum perforatum, rhus toxicodendron, ruta graveolens, veratrum album 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 January 16, 2015

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  • ACTIVE INGREDIENTS:

    CALENDULA OFFICINALIS 3X, 12X, 30X, 100X, 1M, ARNICA MONTANA 3X, 6X, 12X, 100X, 1M, SYMPHYTUM OFFICINALE 5X, MEDULLA OSSIS SUIS 6X, BELLADONNA 6X, 30X, HAMAMELIS VIRGINIANA 12X, HYPERICUM PERFORATUM 12X, RHUS TOXICODENDRON 12X, RUTA GRAVEOLENS 12X, VERATRUM ALBUM 12X

  • INDICATIONS:

    For temporary relief of soreness. Pain and swelling in joints.

  • WARNINGS:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding, ask a health professional before use.

    Do not use if tamper evident seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of soreness. Pain and swelling in joints.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC 29322

  • PACKAGE DISPLAY LABEL:

    Synergy Formulas

    INJURY COMPOSITION

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Injury Composition 2 oz

  • INGREDIENTS AND APPEARANCE
    INJURY COMPOSITION 
    calendula officinalis, arnica montana, symphytum officinale, medulla ossis suis, belladonna, hamamelis virginiana, hypericum perforatum, rhus toxicodendron, ruta graveolens, veratrum album liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0028
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT5 [hp_X]  in 1 mL
    SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8) SUS SCROFA BONE MARROW6 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 1 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK12 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM12 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]  in 1 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43772-0028-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/16/2015
    Labeler - Synergy Formulas, Inc. (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0028) , api manufacture(43772-0028) , label(43772-0028) , pack(43772-0028)
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