Label: THROAT- baptisia, phytolacca, hydrastis, apis mel, arg nit, belladonna, hepar sulph calc, kali bic, lac can, lachesis, merc solub spray

  • NDC Code(s): 43406-0718-2
  • Packager: Natural Creations, 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 December 21, 2018

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Baptisia 6X, Phytolacca 6X, Hydrastis 6X, Apis mel 12X, Arg Nit 12X, Belladonna 12X, Hepar Sulph Calc 12X, Kali Bic 12X, Lac Can 12X, Lachesis 12X, Merc Solub 12X

  • INDICATIONS & USAGE

    USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**

  • PURPOSE

    USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Spray 3 to 5 times towards back of the throat as needed or as directed by a health care professional.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

  • WARNINGS

    WARNINGS:

    • Consult a physician for use in children under 12 years of age.
    • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
    • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
    • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
    • Do not use if TAMPER EVIDENT seal is broken or missing.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Clove Bud, Ethyl Alcohol USP, Glycerin USP, Marshmallow Root, Menthol Crystals, Myrrh Gum, Purified Water, Sage leaves, Thyme Leaves, Yellow Dock Root

  • QUESTIONS

    QUESTIONS & COMMENTS?

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

    *The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

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

  • PRINCIPAL DISPLAY PANEL

    NDC:43406-0718-2

    Throat Spray

    HOMEOPATHIC

    2 fl oz (60mL) / 20% Alcohol

    image description

  • INGREDIENTS AND APPEARANCE
    THROAT 
    baptisia, phytolacca, hydrastis, apis mel, arg nit, belladonna, hepar sulph calc, kali bic, lac can, lachesis, merc solub spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0718
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BAPTISIA TINCTORIA WHOLE (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA WHOLE6 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE12 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE12 [hp_X]  in 1 mL
    CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT) CANIS LUPUS FAMILIARIS MILK12 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    clove (UNII: K48IKT5321)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    MENTHOL (UNII: L7T10EIP3A)  
    MYRRH (UNII: JC71GJ1F3L)  
    sage (UNII: 065C5D077J)  
    THYME (UNII: CW657OBU4N)  
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0718-260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/20/2022
    Labeler - Natural Creations, Inc (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc030572478manufacture(43406-0718)
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