Label: THRUSH NIPPLES- baptisia, bryonia, borax, candida a, calendula, hydrastis, kali chloricum, mercurius sol, nat mur, nux moschata, nux vomica, phosphorus, saccharum album, sulphuricum acidum, staphysagria, spray

  • 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 8, 2013

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  • PRINCIPAL DISPLAY PANEL

    Bottle of Thrush Nipples

  • PURPOSE

    For symptoms associated with

  • INDICATIONS & USAGE

    To be used according to label indications.

  • Active Ingredients:

    Baptisia, Bryonia, Borax, Candida A, Calendula, Hydrastis, Kali Chloricum, Mercurius Sol, Nat Mur, Nux Moschata, Nux Vomica, Phosphorus, Saccharum Album, Sulphuricum Acidum, Staphysagria,

  • Directions:

     Spritz 1 time under the tongue 3 x per day until improvement is seen, then dose 1x per day for 3 days. Dose when symptoms return.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    If no improvement is seen after 7 days or new symptoms develop, discontinue use.

  • Inactive Ingredients:

    In reverse osmosis water with less than 1% alcohol. May contain trace amounts of lactose.

  • INGREDIENTS AND APPEARANCE
    THRUSH NIPPLES 
    baptisia, bryonia, borax, candida a, calendula, hydrastis, kali chloricum, mercurius sol, nat mur, nux moschata, nux vomica, phosphorus, saccharum album, sulphuricum acidum, staphysagria, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT30 [hp_C]  in 30 [hp_C]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]  in 30 [hp_C]
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE30 [hp_C]  in 30 [hp_C]
    CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS30 [hp_C]  in 30 [hp_C]
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP30 [hp_C]  in 30 [hp_C]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL30 [hp_C]  in 30 [hp_C]
    POTASSIUM CHLORATE (UNII: H35KS68EE7) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORATE30 [hp_C]  in 30 [hp_C]
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS30 [hp_C]  in 30 [hp_C]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_C]  in 30 [hp_C]
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG30 [hp_C]  in 30 [hp_C]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]  in 30 [hp_C]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_C]  in 30 [hp_C]
    SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE30 [hp_C]  in 30 [hp_C]
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID30 [hp_C]  in 30 [hp_C]
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED30 [hp_C]  in 30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59667-0002-130 [hp_C] in 1 BOTTLE, SPRAY08/05/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/05/2013
    Labeler - Home Sweet Homeopathics (078883277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nichole Michelle Langham078883277manufacture(59667-0002) , label(59667-0002) , pack(59667-0002) , distributes drug products under own private label(59667-0002)