Label: CELL SALTS- calc. fluor., calc. phos., calc.sulph., ferrum phosphoricum, kali mur., kali phos., kali sulph., mag. phos., nat. mur., nat. phos., nat.sulphuricum, silicea liquid

  • NDC Code(s): 55714-2402-0, 55714-2402-1, 55714-2402-2
  • 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 November 7, 2018

If you are a consumer or patient please visit this version.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

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  • OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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  • WARNINGS SECTION

    WARNINGS: 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.

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  • QUESTIONS SECTION

    newtonlabs.net - Questions? 800 448-7256

    Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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  • INACTIVE INGREDIENT SECTION

    USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

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  • OTC - PURPOSE SECTION

    A formulation of the 12 tissue salts.

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  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Calc. fluor. 10x, Calc. phos. 10x, Calc.sulph. 10x, Ferrum phos. 10x, Kali mur. 10x, Kali phos. 10x, Kali sulph. 10x, Mag. phos. 10x, Nat. mur. 10x, Nat. phos. 10x, Nat.sulphuricum 10x, Silicea 10x.

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  • DOSAGE & ADMINISTRATION SECTION

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

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  • INDICATIONS & USAGE SECTION

    A formulation of the 12 tissue salts.

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  • PACKAGE LABEL
  • INGREDIENTS AND APPEARANCE
    CELL SALTS 
    calc. fluor., calc. phos., calc.sulph., ferrum phosphoricum, kali mur., kali phos., kali sulph., mag. phos., nat. mur., nat. phos., nat.sulphuricum, silicea liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2402
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 10 [hp_X]  in 1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE 10 [hp_X]  in 1 mL
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS 10 [hp_X]  in 1 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 10 [hp_X]  in 1 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 10 [hp_X]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 10 [hp_X]  in 1 mL
    POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG) POTASSIUM SULFATE 10 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 10 [hp_X]  in 1 mL
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 10 [hp_X]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 10 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 [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:55714-2402-0 15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/07/2018
    2 NDC:55714-2402-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/07/2018
    3 NDC:55714-2402-2 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/07/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 11/07/2018
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    Name Address ID/FEI Business Operations
    Newton Laboratories, Inc. 788793610 manufacture(55714-2402)
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