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 February 6, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients**

    Arnica montana 9C HPUS (6.67 mg)

    Sarcolacticum acidum 3C HPUS (6.67 mg)

    Zincum oxydatum 3C (6.67 mg)

  • PURPOSE

    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

    Uses*

    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 for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

  • 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older: At the onset of symptoms, chew or allow 1 tablet to dissolve in the mouth, up to 6 times per day. For exercise-induced cramps and spasms, take before, during, and after activity. Contains dextrose; consider rinsing mouth with water if taken at bedtime.

    Children under 12 years of age: Not recommended.

  • SPL UNCLASSIFIED SECTION

    do not use if glued carton end flaps are open or if the plastic sleeve around the tube is broken or missing

    contains 1.6 g of sugar per tablet

    store below 77° F (25°C)

  • INACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    3 Tubes 11 Tablets Each Total 33 Tablets

    Natural lemon flavor

    No Known Drug Interactions

    Am & PM Formula

    Leg Cramp Relief*

    Cramps Spasms*

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

  • QUESTIONS

    Quesions or comments?

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Made in France

    Distributed by: Boiron Inc.

    Newtown Square, PA 19073-3267

  • PRINCIPAL DISPLAY PANEL

    labelLabelboxtube

  • 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
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    LEMON (UNII: 24RS0A988O)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    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
    2NDC:0220-9073-0611 in 1 TUBE; Type 0: Not a Combination Product06/15/2018
    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)
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