| NDC | 70965-002-02 |
| Set ID | bb65a25a-6c5b-4773-8eed-b08cd76348d4 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Breakthrough M2 Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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ACTIVE INGREDIENT
Active Ingredients (HPUS*)
equal amounts of: Calcarea Carbonica 12X, Capsicum Annuum 6X, Ferrum Metallicum 12X, Glandula Suprarenalis 8X, Graphites 12X, Hepar Suis 10X, Hypothalamus 18X, Iodium 6X, Kali Carbonicum 6X, Oophorinum 8X, Pancreatinum 12X, Phytolacca Decandra 12X, Pulsatilla 30X, Sepia 30X.
†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
*The letters "HPUS" indicate that the componenets in this product are officially monographed in the Homeopathic Pharmacopoeia of the
Unitied Sates.
- INDICATIONS & USAGE
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WARNINGS
Warnings
- This product is not intended for use by children under 18 years of age.
- IF PREGNANT OR NURSING or taking any medication, ask a healthcare professional before use.
- KEEP OUT OF REACH OF CHILDERN. In case of accidental overdose, get medical help or contact a Poison Control Center immediately (800-222-1222).
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WOMENS PLATINUM
calcarea carbonica, capsicum annuum, ferrum metallicum, glandula suprarenalis, graphites, hepar suis, hypothalamus, iodium, kali carbonicum, oophorinum, pancreatinum, phytolacca decandra, pulsatilla, sepia. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70965-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X] in 59 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 6 [hp_X] in 59 mL IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 12 [hp_X] in 59 mL SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND 8 [hp_X] in 59 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 12 [hp_X] in 59 mL PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER 10 [hp_X] in 59 mL BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS 18 [hp_X] in 59 mL IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 6 [hp_X] in 59 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 6 [hp_X] in 59 mL SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY 8 [hp_X] in 59 mL PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE 12 [hp_X] in 59 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 12 [hp_X] in 59 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 30 [hp_X] in 59 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 30 [hp_X] in 59 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:70965-002-02 59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 10/10/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/10/2016 Labeler - Breakthrough M2 Inc (039423774) Registrant - OHM PHARMA INC. (030572478) Establishment Name Address ID/FEI Business Operations OHM PHARMA INC. 030572478 manufacture(70965-002)
