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

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  • 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

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  • INDICATIONS & USAGE

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

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  • STOP USE

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

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  • ASK DOCTOR

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

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  • PREGNANCY OR BREAST FEEDING

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

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  • 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.

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  • SPL UNCLASSIFIED SECTION

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

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  • INACTIVE INGREDIENT

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

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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    ARNICARE LEG CRAMPS 
    arnica montana, lactic acid, l-, zinc oxide tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9073
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 9 [hp_C]
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3 [hp_C]
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 3 [hp_C]
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white Score score with uneven pieces
    Shape ROUND Size 20mm
    Flavor LEMON Imprint Code none
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0220-9073-90 33 in 1 PACKAGE 06/15/2018
    1 11 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/15/2018
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    Name Address ID/FEI Business Operations
    Boiron 282560473 manufacture(0220-9073)
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