Label: D-133- calcium fluoride, silicon dioxide, tribasic calcium phosphate, calcium sulfate anhydrous, ferrosoferric phosphate, potassium chloride, dibasic potassium phosphate, potassium sulfate, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, sodium chloride, and sodium sulfate solution
- NDC Code(s): 58264-0139-1
- Packager: DNA Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
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 June 5, 2022
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- SPL UNCLASSIFIED SECTION
- INDICATIONS
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INGREDIENTS
ACTIVE
Calcarea fluorica 8x, 12x, 30x, Calcarea phosphorica 6x, 12x, 30x, Calcarea sulphurica 6x, 12x, 30x, Ferrum phosphoricum 6x, 12x, 30x, Kalium muriaticum 6x, 12x, 30x, Kalium phosphoricum 6x, 12x, 30x, Kalium sulphuricum 6x, 12x, 30x, Magnesia phosphorica 6x, 12x, 30x, Natrum phosphoricum 6x, 12x, 30x, Natrum muriaticum 6x, 12x, 30x, Natrum sulphuricum 6x, 12x, 30x, Silicea 8x, 12x, 30x
- SUGGESTED DOSAGE
- STORAGE AND HANDLING
- Warnings
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
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INGREDIENTS AND APPEARANCE
D-133
calcium fluoride, silicon dioxide, tribasic calcium phosphate, calcium sulfate anhydrous, ferrosoferric phosphate, potassium chloride, dibasic potassium phosphate, potassium sulfate, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, sodium chloride, and sodium sulfate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58264-0139 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 8 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE 6 [hp_X] in 1 mL CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS 6 [hp_X] in 1 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 6 [hp_X] in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 6 [hp_X] in 1 mL DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) DIBASIC POTASSIUM PHOSPHATE 6 [hp_X] in 1 mL POTASSIUM SULFATE (UNII: 1K573LC5TV) (POTASSIUM CATION - UNII:295O53K152, SULFATE ION - UNII:7IS9N8KPMG) POTASSIUM SULFATE 6 [hp_X] in 1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X] in 1 mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 6 [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:58264-0139-1 29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/01/1990 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/1990 Labeler - DNA Labs, Inc. (031784339)
