Label: DAIRY ANTIGENS (calcarea carbonica, lac defloratum, sepia, sulphur, american cheese, cheese (stilton), cheese- camembert, cheddar cheese, cottage cheese, lac caprinum, lac vaccinum, swiss cheese 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 April 9, 2020

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  • ACTIVE INGREDIENTS:

    Calcarea Carbonica 12X, Lac Defloratum 12X, Sepia 12X, Sulphur 12X, American Cheese 12X, 15X, 18x, 33X, Cheese (Stilton) 12X, 15X, 18x, 33X, Cheese (Camembert) 12X, 15X, 18X, 33X, Cheddar Cheese 12X, 15X, 18X, 33X, Cottage Cheese 12X, 15X, 18X, 33X, Lac Caprinum 12X, 15X, 18X, 33X, Lac Vaccinum 12X, 15X, 18X, 33X, Swiss Cheese 12X, 15X, 18X, 33X.

  • INDICATIONS:

    For temporary relief of allergies due to milk products.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

  • 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.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of allergies due to milk products.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    DAIRY ANTIGENS

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Dairy Antigens

  • INGREDIENTS AND APPEARANCE
    DAIRY ANTIGENS 
    calcarea carbonica, lac defloratum, sepia, sulphur, american cheese, cheese (stilton), cheese (camembert), cheddar cheese, cottage cheese, lac caprinum, lac vaccinum, swiss cheese liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0554
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6) WHEY12 [hp_X]  in 1 mL
    CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED (UNII: IYI0G2057S) (CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED - UNII:IYI0G2057S) CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED12 [hp_X]  in 1 mL
    CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED (UNII: G44KTI7KIS) (CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED - UNII:G44KTI7KIS) CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED12 [hp_X]  in 1 mL
    CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED (UNII: CJP9NL7JSJ) (CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED - UNII:CJP9NL7JSJ) CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED12 [hp_X]  in 1 mL
    CASEIN, LACTOCOCCUS LACTIS CULTURED (UNII: 489F5JNV5B) (CASEIN, LACTOCOCCUS LACTIS CULTURED - UNII:489F5JNV5B) CASEIN, LACTOCOCCUS LACTIS CULTURED12 [hp_X]  in 1 mL
    GOAT MILK (UNII: XE5K5I4RP7) (GOAT MILK - UNII:XE5K5I4RP7) GOAT MILK12 [hp_X]  in 1 mL
    COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK12 [hp_X]  in 1 mL
    CASEIN, EMMENTAL CULTURED (UNII: 13811K7P3X) (CASEIN, EMMENTAL CULTURED - UNII:13811K7P3X) CASEIN, EMMENTAL CULTURED12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0554-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/09/2020
    Labeler - BioActive Nutritional (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0554) , api manufacture(43857-0554) , label(43857-0554) , pack(43857-0554)
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