Label: ROSAREX- calc phos, calc sil, carbo veg, kali brom, viola tri 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 August 9, 2012

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  • PURPOSE

    Reduces facial redness, flushing and bumpy texture

  • ACTIVE INGREDIENT

    Active Ingredients: Each serving contains equal parts of: Calc phos 8X HPUS, Calc sil 30C HPUS, Carbo veg 30C HPUS, Kali brom 30C HPUS, Viola tric 6C HPUS.

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings: If symptoms persist or worsen, consult a healthcare professional.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help of contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: For all ages: Dissolve 2 tablets in a clean mouth 3 times daily. Special instructions: May be repeated every half hour if necessary. Avoid strong mint-flavored candy.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Acacia gum, lactose, magnesium stearate, corn starch, sucrose.

  • INFORMATION FOR PATIENTS

    The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    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

    Contains no artificial flavors or artificial colors. No gluten added.

  • STORAGE AND HANDLING

    Tamper resistant for your protection. Use only if safety seal is intact.

  • PRINCIPAL DISPLAY PANEL

    Bottle label
  • INGREDIENTS AND APPEARANCE
    ROSAREX  
    calc phos, calc sil, carbo veg, kali brom, viola tri tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-067
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE8 [hp_X]
    CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE30 [hp_C]
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL30 [hp_C]
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM BROMIDE30 [hp_C]
    VIOLA TRICOLOR (UNII: 9Q24RAI43V) (VIOLA TRICOLOR - UNII:9Q24RAI43V) VIOLA TRICOLOR6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (White lactose tablets) Scoreno score
    ShapeROUND (Round white lactose tablets) Size5mm
    FlavorImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-067-80180 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2012
    Labeler - Native Remedies, LLC (192014186)
    Registrant - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350api manufacture(68703-067) , manufacture(68703-067)
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