Mens 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#
ProductMens PLATINUM
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAPSICUM, IRON, SUS SCROFA ADRENAL GLAND, GRAPHITE, PORK LIVER, BOS TAURUS HYPOTHALAMUS, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PANCRELIPASE, PHYTOLACCA AMERICANA ROOT, SUS SCROFA TESTICLE
Label structure8 sections
Contacts and useful links#
Websitewww.breakthroughm2.com
www.breakthroughM2.com
www.breakthroughM2.comLabel 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, Kali Carbonicum 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 30X, Pancreatinum 12X, Phytolacca Decandra 12X, Orchitinum 8X.
†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
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 CHILDREN . 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 swallowing. Consult a physician 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 70965-001-02
Breakthrough M2
Homeopathic PLATINUM®
MEN
2 fl oz (60 ml)
Ethyl Alcohol 20%
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#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70965-001-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-565d-a910-e053-dadaa90a0b85 | Breakthrough M2 Men's PLATINUM |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70965-001-02 | Mens PLATINUM | 59 mL in 1 BOTTLE, DROPPER | LIQUID | 59 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70965-001 | MENS PLATINUM (CALCAREA CARBONICA, CAPSICUM ANNUUM, FERRUM METALLICUM, GLANDULA SUPRARENALIS, GRAPHITES, HEPAR SUIS, HYPOTHALAMUS, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PANCREATINUM, PHYTOLACCA DECANDRA, ORCHITINUM.) LIQUID [BREAKTHROUGH M2 INC] | 2 | Legacy NDC, 1 package rows | 20181024_c7cbf2d4-81f0-4668-91f8-ed43a420be84.zip |
Products#
Every source-derived product name is available through these pages.
- Mens PLATINUM
- Calcarea Carbonica, Capsicum Annuum, Ferrum Metallicum, Glandula Suprarenalis, Graphites, Hepar Suis, Hypothalamus, Kali Carbonicum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Pancreatinum, Phytolacca Decandra, Orchitinum.
- OYSTER SHELL CALCIUM CARBONATE, CRUDE
- CAPSICUM
- IRON
- SUS SCROFA ADRENAL GLAND
- GRAPHITE
- PORK LIVER
- BOS TAURUS HYPOTHALAMUS
- POTASSIUM CARBONATE
- CARBONATE ION
- LYCOPODIUM CLAVATUM SPORE
- SODIUM CHLORIDE
- CHLORIDE ION
- STRYCHNOS NUX-VOMICA SEED
- PANCRELIPASE
- PANCRELIPASE LIPASE
- PHYTOLACCA AMERICANA ROOT
- SUS SCROFA TESTICLE
- WATER
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70965-001 | 70965-001-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 2E32821G6I | ACTIB |
| CAPSICUM | 00UK7646FG | ACTIB |
| IRON | E1UOL152H7 | ACTIB |
| SUS SCROFA ADRENAL GLAND | 398IYQ16YV | ACTIB |
| GRAPHITE | 4QQN74LH4O | ACTIB |
| PORK LIVER | 6EC706HI7F | ACTIB |
| BOS TAURUS HYPOTHALAMUS | S6G2NLH4Y7 | ACTIB |
| POTASSIUM CARBONATE | BQN1B9B9HA | ACTIB |
| LYCOPODIUM CLAVATUM SPORE | C88X29Y479 | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
| PANCRELIPASE | FQ3DRG0N5K | ACTIM |
| PHYTOLACCA AMERICANA ROOT | 11E6VI8VEG | ACTIB |
| SUS SCROFA TESTICLE | KM02613O28 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2ea96a69-e4ea-4f4b-a090-8bf2161b46cd | c7cbf2d4-81f0-4668-91f8-ed43a420be84 | 2018-10-23 | Warnings | 2ea96a69-e4ea-4f4b-a090-8bf2161b46cd c7cbf2d4-81f0-4668-91f8-ed43a420be84 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.