Label: PRE POST SURGERY HP- arnica montana, bellis perennis, bryonia, calendula officinalis, hypericum perforatum, ledum palustre, phosphorus, pyrogenium, rhus toxicodendron, 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 October 1, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Arnica montana 6X, 12X, Bellis perennis 12X, Bryonia 12X, Calendula officinalis 3X, Hypericum perforatum 12X, Ledum palustre 12X, Phosphorus 12X, Pyrogenium 30X, Rhus toxicodendron 12X, Ruta graveolens 12X, Staphysagria 12X, Symphytum officinale 3X.

  • PURPOSE

    INDICATIONS:  For temporary relief of sprains, strains, bumps and bruises.

  • WARNINGS

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

    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.  Store in a cool, dry place.

  • DOSAGE & ADMINISTRATION

    SUGGESTED DOSAGE:  10 drops orally, 3-4 times a day or as directed by a health care professional.  Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.


  • 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.


  • INDICATIONS & USAGE

    INDICATIONS:  For temporary relief of sprains, strains, bumps, and bruises.

  • QUESTIONS

    Manufactured For:

    The Maplewood Company

    7075 E. Maplewood Plaza

    Englewood, CO 80111


  • PRINCIPAL DISPLAY PANEL

    PRE/POST SURGERY HP

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Pre/Post Surgery HP

  • INGREDIENTS AND APPEARANCE
    PRE POST SURGERY  HP
    arnica montana, bellis perennis, bryonia, calendula officinalis, hypericum perforatum, ledum palustre, phosphorus, pyrogenium, rhus toxicodendron, liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0156
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_X]  in 1 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS12 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_X]  in 1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM12 [hp_X]  in 1 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [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
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED12 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0156-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/01/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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