Label: CALCAREA FLUORICA- calcarea fluorica liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-6117-1 - Packager: Newton Laboratories, 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 September 1, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
- ACTIVE INGREDIENT SECTION
- PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
CALCAREA FLUORICA
calcarea fluorica liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-6117 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O) Calcium Fluoride 15 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-6117-1 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-6117)
