FDA.reportPublic FDA data

Womens PLATINUM

Manufacturer
Breakthrough M2 Inc | OHM PHARMA INC.
Effective date
2018-10-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:30

Label at a glance#

ProductWomens PLATINUM
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAPSICUM, IRON, SUS SCROFA ADRENAL GLAND, GRAPHITE, PORK LIVER, BOS TAURUS HYPOTHALAMUS, IODINE, POTASSIUM CARBONATE, SUS SCROFA OVARY, PANCRELIPASE, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 SECTION

Uses:

Temporarily gives support during weight management program.†

WARNINGS SECTION

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).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION SECTION

​Directions: ​Use only as directed. Shake well before use. Take 12 drops, 3 times a day, 30 minutes before meals. Place drops under the tongue and hold for 10-15 seconds before starting any diet/exercise program.

OTHER SAFETY INFORMATION

Other information:  • Store at room temperature away from heat and sunlight. • Do not use if tamper evident neck seal is missing or broken.

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Ethyl Alcohol, Purified Water

OTC - QUESTIONS SECTION

Distributed By​​​

Breakthrough M2 Inc.

2308 St. Rte 208, Montgomery, NY 12549

 (845) 713-4320

Visit www.breakthroughM2.com

Made in USA in FDA inspected facility.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70965-002-02

Breakthrough

M2

Homeopathic 

PLATINUM®

​WOMEN

2 fl oz (60 mL)

Ethyl Alcohol 20%

2oz bottle label2oz bottle label

OTC - PURPOSE SECTION

Purpose: Supports healthy sleep, stable mood, lower stress levels, body processes and organ support while following a healthy weight management diet and exercise regimen.†

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70965-002-022021-01-29C16284748780-1ba0f9c33-2d81-a910-e053-dadaa90a0b85Breakthrough M2 Women's PLATINUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70965-002-02Womens PLATINUM59 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70965-002WOMENS PLATINUM (CALCAREA CARBONICA, CAPSICUM ANNUUM, FERRUM METALLICUM, GLANDULA SUPRARENALIS, GRAPHITES, HEPAR SUIS, HYPOTHALAMUS, IODIUM, KALI CARBONICUM, OOPHORINUM, PANCREATINUM, PHYTOLACCA DECANDRA, PULSATILLA, SEPIA.) LIQUID [BREAKTHROUGH M2 INC]2Legacy NDC, 1 package rows20181024_bb65a25a-6c5b-4773-8eed-b08cd76348d4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70965-00270965-002-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CAPSICUM00UK7646FGACTIB
IRONE1UOL152H7ACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
GRAPHITE4QQN74LH4OACTIB
PORK LIVER6EC706HI7FACTIB
BOS TAURUS HYPOTHALAMUSS6G2NLH4Y7ACTIB
IODINE9679TC07X4ACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
PANCRELIPASEFQ3DRG0N5KACTIM
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d9b2b5dd-c304-4dd4-883d-4b3529b58d82bb65a25a-6c5b-4773-8eed-b08cd76348d42018-10-23WarningsExact identifier
spl id: d9b2b5dd-c304-4dd4-883d-4b3529b58d82
spl set id: bb65a25a-6c5b-4773-8eed-b08cd76348d4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.