CALCAREA FLUORICA - calcarea fluorica liquid 
Newton Laboratories, Inc.

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.

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Calcarea fluorica

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

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)

Revised: 9/2011
Document Id: c1a95727-dbc8-e388-1347-f18da842f144
Set id: 68cb2dbf-ea06-3ef3-185c-0059f12cab2c
Version: 1
Effective Time: 20110901
 
Newton Laboratories, Inc.