Label: ROSAREX- carbo veg, calc phos , kali brom, calc sil violo tric , lactose . tablet

  • 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 July 19, 2010

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  • DESCRIPTION

    Reduces facial redness, flushing and bumpy texture

  • INDICATIONS & USAGE

    Indications: Homeopathic remedy for red, inflamed skin on the face.

  • DOSAGE & ADMINISTRATION

    Dosage: Dissolve 2 tablets in a clean mouth 3 times daily. May be repeated every half hour if necessary. May be used with MediAc™  for combined support.

  • GENERAL PRECAUTIONS

    Caution: If symptoms persist or worsen, a health care professional should be consulted. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medicines from the reach of children.

  • ACTIVE INGREDIENT

    Ingredients: Each dose contains equal parts of Carbo veg (30C) (HPUS), Calc phos (6X) (HPUS), Kali brom (30C) (HPUS), Calc sil (30C) (HPUS), Violo tric (6C) (HPUS)

  • INACTIVE INGREDIENT

    Lactose (inactive ingredient).

  • PREGNANCY

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

  • USER SAFETY WARNINGS

    Contains no gluten, artificial flavors, colors or preservatives. Safe for all ages and during pregnancy.

  • INFORMATION FOR PATIENTS

    All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

    Distributed by

    Native Remedies, LLC

    6531 Park of Commerce Blvd.

    Suite 160

    Boca Raton, FL 33487

    Phone: 1.877.289.1235

    International: + 1.561.999.8857

    The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    ROSAREX 
    carbo veg, calc phos , kali brom, calc sil violo tric , lactose . tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68647-118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL30 [hp_C]
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE6 [hp_X]
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM BROMIDE30 [hp_C]
    CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE30 [hp_C]
    VIOLA TRICOLOR (UNII: 9Q24RAI43V) (VIOLA TRICOLOR - UNII:9Q24RAI43V) VIOLA TRICOLOR6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (white lactose tablets) Scoreno score
    ShapeROUND (round white lactose tablets) Size5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68647-118-10125 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/19/2010
    Labeler - Feelgood Health (538418296)
    Establishment
    NameAddressID/FEIBusiness Operations
    W.Last567284153manufacture
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