Label: ARNICA liquid

  • NDC Code(s): 0395-0115-94
  • Packager: Humco Holding Group, Inc.
  • 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 13, 2020

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

  • SPL UNCLASSIFIED SECTION

    HUMCO Arnica Tincture

    Drug Facts

  • Active Ingredient

    Arnica Flowers, 20 grams per 100cc of tincture

  • Purpose

    Soreness relief

  • USE:

    For the temporary relief of bruises and soreness.

  • Warnings

    When using this product

    do not apply to irritated skin. Avoid getting into eyes or on mucous membranes.

    Stop use and consult a doctor

    if a rash or excessive irritation of the skin develops.

    Keep out of reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. If pregnant or breastfeeding ask a health professional before use.

  • Directions

    • When applied as a tincture, dilute with one or two parts of Rubbing Alcohol.
    • May be added to hot water that is being used in hot packs.
    • Apply to affected area, repeat as needed.

    These statements have not been evaluated by the FDA. This product is not intended to diagnose, cure, treat or prevent any disease.

  • Inactive Ingredient

    Isopropyl Alcohol and Purified Water.

  • Other Information

    • Flammable: Keep away from spark, heat and flame. Store in cool dry place.
  • Principal Display Panel

    NDC 0395-0115-94
    ARNICA TINCTURE
    Soreness relief
    4 fl oz (118 mL)

    Principal Display Panel
NDC 0395-0115-94
ARNICA TINCTURE
Soreness relief
4 fl oz (118 mL)

  • INGREDIENTS AND APPEARANCE
    ARNICA 
    arnica liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-0115-94118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/199706/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/199706/30/2022
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-0115) , analysis(0395-0115) , pack(0395-0115) , label(0395-0115)