Label: KALMIA COMBINATION 9228- kalmia combination liquid

  • 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 August 15, 2019

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  • ACTIVE INGREDIENTS

    Asafoetida 8X
    Kalmia latifolia 8X
    Causticum 10X
    Colchicum autumnale 10X
    Ferrum metallicum 10X
    Gnaphalium polycephalum 10X
    Lithium benzoicum 10X
    Mercurius praecipitatus ruber 10X
    Rhus toxicodendron 10X
    Spiraea ulmaria 10X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of minor pain, stiffness, or inflammation of joints or connective tissue.*

  • PURPOSE

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS

    In case of overdose, get medical help or contact a poison control center right away.

    Keep out of the reach of children.

    If pregnant or breastfeeding, ask a healthcare professional before use.

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    40% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Kalmia Combination

    Homeopathic Remedy

    1 FL. OZ. (29.5 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    KALMIA COMBINATION  9228
    kalmia combination liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-9228
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (FERULA ASSA-FOETIDA RESIN - UNII:W9FZA51AS1) FERULA ASSA-FOETIDA RESIN8 [hp_X]  in 29.5 mL
    KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18) KALMIA LATIFOLIA LEAF8 [hp_X]  in 29.5 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 29.5 mL
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB10 [hp_X]  in 29.5 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON10 [hp_X]  in 29.5 mL
    PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE10 [hp_X]  in 29.5 mL
    LITHIUM BENZOATE (UNII: R9Z042Z19E) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM BENZOATE10 [hp_X]  in 29.5 mL
    MERCURIC OXIDE (UNII: IY191986AO) (MERCURIC OXIDE - UNII:IY191986AO) MERCURIC OXIDE10 [hp_X]  in 29.5 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 29.5 mL
    FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) (FILIPENDULA ULMARIA ROOT - UNII:997724QNDS) FILIPENDULA ULMARIA ROOT10 [hp_X]  in 29.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-9228-129.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-9228)
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