Label: TEETHING-HP- borax, calcarea carbonica, calcarea phosphorica, chamomilla, passiflora incarnata, podophyllinum, silicea liquid
- NDC Code(s): 43857-0447-1
- Packager: BioActive Nutritional, 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 June 16, 2017
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
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INGREDIENTS AND APPEARANCE
TEETHING-HP
borax, calcarea carbonica, calcarea phosphorica, chamomilla, passiflora incarnata, podophyllinum, silicea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0447 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 30 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 30 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 30 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 30 [hp_X] in 1 mL PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM 30 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43857-0447-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/16/2017 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0447, 43857-0447) , api manufacture(43857-0447) , pack(43857-0447)