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

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.

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Breakthrough M2 Men's PLATINUM

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. 

Uses:

Temporarily gives support during weight management program.

Warnings:

​KEEP OUT OF REACH OF CHILDREN.

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 Information:

Inactive ingredients:

Ethyl Alcohol, Purified Water.

​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.

NDC 70965-001-02

Breakthrough M2

Homeopathic PLATINUM®

MEN

2 fl oz (60 ml)

Ethyl Alcohol 20%

2oz bottle label

Purpose:

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

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70965-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 59 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM6 [hp_X]  in 59 mL
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON12 [hp_X]  in 59 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND8 [hp_X]  in 59 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE12 [hp_X]  in 59 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER10 [hp_X]  in 59 mL
BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS18 [hp_X]  in 59 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE6 [hp_X]  in 59 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 59 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_X]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]  in 59 mL
PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE12 [hp_X]  in 59 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT12 [hp_X]  in 59 mL
SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28) SUS SCROFA TESTICLE8 [hp_X]  in 59 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70965-001-0259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/10/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/10/2016
Labeler - Breakthrough M2 Inc (039423774)
Registrant - OHM PHARMA INC. (030572478)
Establishment
NameAddressID/FEIBusiness Operations
OHM PHARMA INC.030572478manufacture(70965-001)

Revised: 10/2018
Document Id: 2ea96a69-e4ea-4f4b-a090-8bf2161b46cd
Set id: c7cbf2d4-81f0-4668-91f8-ed43a420be84
Version: 2
Effective Time: 20181023
 
Breakthrough M2 Inc