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 1, 2024

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

View All Sections
  • 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 ... Temporarily relieves minor pain, stiffness & muscle soreness due to overexertion

    Sarcolacticum acidum 3C HPUS ... Relieves muscle fatigue after prolonged exercise & muscle cramping

    Zincum oxydatum 3C ... Relieves muscle cramping

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves minor muscle pain from cramps, stiffness, and muscular fatigue due to prolonged exercise and physical activity

  • 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.

  • 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: Chew 1 tablet in the mouth immediately prior, during, and after physical activity every hour until symptoms improve, up to 10 tablets a day.

    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

    retain carton for full drug facts

    contains 1.6 g of sugar per tablet

    store below 77° F (25°C)

  • INACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    3 Tubes 11 Tablets Each Total 33 Tablets

    Natural lemon flavor

    No Known Drug Interactions

    Leg Cramp Relief*

    Cramps Spasms*

    Target Relief of main sources of exercise-induced muscle pain

    *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

    labellabellabelLabelboxtube

  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!