CALCAREA FLUORICA (CALCAREA FLUORICA) LIQUID [NEWTON LABORATORIES, INC.]

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CALCAREA FLUORICA (CALCAREA FLUORICA) LIQUID [NEWTON LABORATORIES, INC.]
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NDC 55714-6117-1
Set ID 68cb2dbf-ea06-3ef3-185c-0059f12cab2c
Category HUMAN OTC DRUG LABEL
Packager Newton Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • INDICATIONS & USAGE SECTION

    Cell Salts, Varicose Veins, Bone Spurs, Croup, Deficient Tooth Enamel, Cysts.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.  Sensitive persons begin with 1 drop and gradually increase to full dose.

  • ACTIVE INGREDIENT SECTION

    Calcarea fluorica 15x, 10x, 200c, 30c.

  • PURPOSE SECTION

    Cell Salts, Varicose Veins, Bone Spurs, Croup, Deficient Tooth Enamel, Cysts.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%. 

  • QUESTIONS SECTION

    www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions? 1.800.448.7256

  • WARNINGS SECTION

    Warning: Keep out of reach of children.  Do not use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a  few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a doctor before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package image

  • INGREDIENTS AND APPEARANCE
    CALCAREA FLUORICA  
    calcarea fluorica liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-6117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O) Calcium Fluoride15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-6117-130 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-6117)
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