Label: MACULA- calcium fluoride, calcium phosphate, carbon disulfide, dibasic potassium phosphate, sodium chloride pellet
- NDC Code(s): 68770-190-42
- Packager: Natural Ophthalmics, 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 December 31, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings:
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- Directions:
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SPL UNCLASSIFIED SECTION
Do not use if tamper evident seal is broken.
*The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
† Claims based on traditional homeopathic practice, not accepted medical evidence.
Not FDA evaluated.Manufactured for: Natural Ophthalmics, Inc. PO Box 1510 Dillon, CO 80435 PH: 877-220-9710
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INGREDIENTS AND APPEARANCE
MACULA
calcium fluoride, calcium phosphate, carbon disulfide, dibasic potassium phosphate, sodium chloride pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68770-190 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 12 [hp_X] CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8) CARBON DISULFIDE 11 [hp_X] POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 7 [hp_X] SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 9 [hp_X] CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE 10 [hp_X] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68770-190-42 600 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/27/2022 Labeler - Natural Ophthalmics, Inc (118039333)