Label: ARNICARE LEG CRAMPS- arnica montana, lactic acid, l-, zinc oxide 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 May 4, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Arnica montana 9C HPUS

    Sarcolacticum acidum 3C HPUS

    Zincum oxydatum 3C

  • PURPOSE

    Arnica montana 9C HPUS Relieves muscle fatigue causing or caused by cramps

    Sarcolacticum acidum 3C HPUS Relieves pain and stiffness from muscular overexertion

    Zincum oxydatum 3C Relieves day and night muscle cramps

  • INDICATIONS & USAGE

    Temporarily relieves day and night cramps and spasms in calves, legs, thighs, and arms and cramps from muscular overexertion.

  • WARNINGS

  • STOP USE

    Stop use and ask a doctor if symptoms persist fro more than 3 days or worsen

  • ASK DOCTOR

    Ask a doctor before use if you have diabetes (each tablet contains 1.6g dextrose)

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Adults and children age 12 and up: chew or allow 1 tablet to dissolve in the mouth at bedtime and if cramps occur, up to 6 times per day. Take before, during, and after exercise. Contains dextrose; consider rinsing mouthwith water before going to sleep.

  • SPL UNCLASSIFIED SECTION

    stay hydrated, practice regular physical activity, store at 68-77F (2-25C)

  • INACTIVE INGREDIENT

    dextrose, lactose, magnesium stearate, citric acid, natural lemon flavor

  • SPL UNCLASSIFIED SECTION

    These "Uses" have not been evaluated by the Food and Drug Administration.

    C, CK, and X are homeopathic dilutions: see BoironUSA.com/info for details

  • QUESTIONS

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Distributed by: Boiron Inc.

    6 Campus Blvd.

    Newtown Square, PA 19073-3267

  • PRINCIPAL DISPLAY PANEL

    boxtube

  • INGREDIENTS AND APPEARANCE
    ARNICARE LEG CRAMPS 
    arnica montana, lactic acid, l-, zinc oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9073
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA9 [hp_C]
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 [hp_C]
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L-3 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    LEMON (UNII: 24RS0A988O)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize20mm
    FlavorLEMONImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9073-9033 in 1 PACKAGE06/15/2018
    111 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/15/2018
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9073)