Label: DR. RECKEWEG R55 RUTAVINE COMBINATION PRODUCT- arnica montana, radix 3x, belladonna 4x, calendula officinalis 3x, echinacea 3x, hamamelis virginiana 4x, rhus toxicodendron 6x, ruta graveolens 6x, symphytum officinale 6x 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 May 15, 2013

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  • ACTIVE INGREDIENT

    Active ingredients

    Arnica montana, radix 3X, Belladonna 4X, Calendula officinalis 3X, Echinacea 3X, Hamamelis virginiana 4X, Rhus toxicodendron 6X, Ruta graveolens 6X, Symphytum officinale 6X,

    1 g each in 10 g.

  • PURPOSE


    Purpose

    Relieves minor joint or muscular pain or minor pain due to injuries, sprains, bruising

  • INDICATIONS & USAGE


    Uses

    For the temporary relief of minor joint or muscular pain or minor pain due to:


    • Injuries
    • Sprains
    • Bruising
  • WARNINGS

    Warnings

    Stop use and ask a doctor if symptoms persist, get worse, or if new symptoms occur.

    If pregnant or breastfeeding, ask a health care professional before use.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION


    Directions

    Adults and children ≥ 12 years 10-15 drops 1-3 times daily; acute cases:

    10-15 drops every 15-60 minutes (up to 12 times per day) or until improvement of symptoms in a little water or undiluted or as recommended.

  • OTHER SAFETY INFORMATION

    Other information

    • Tamper resistant: do not use if safety ring at base of cap is broken.
    • Retain outer carton for full product information.

  • INACTIVE INGREDIENT


    Inactive ingredients

    Ethanol, purified water.

  • QUESTIONS

    Questions?

    Call 1.800.361.7872 or email questions@reckeweg.com

  • PRINCIPAL DISPLAY PANEL

    image of carton label

    NDC# 53346-1355-5

    Dr. Reckeweg R55 Rutavine
    Homeopathic preparation for the temporary relief of minor joint or muscular pain or minor pain due to:

    • Injuries
    • Sprains
    • Bruising


    Manufactured by:
    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R55 RUTAVINE  COMBINATION PRODUCT
    arnica montana, radix 3x, belladonna 4x, calendula officinalis 3x, echinacea 3x, hamamelis virginiana 4x, rhus toxicodendron 6x, ruta graveolens 6x, symphytum officinale 6x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1355
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]  in 50 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]  in 50 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 50 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [hp_X]  in 50 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 4 [hp_X]  in 50 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]  in 50 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]  in 50 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1355-550 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/1986
    Labeler - PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO (318602612)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO318602612manufacture(53346-1355)
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