Breakthrough M2 Women'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, 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.

Uses:

Temporarily gives support during weight management program.†

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).

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 starting any diet/exercise program.

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

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 70965-002-02

Breakthrough

Homeopathic

PLATINUM®

WOMEN

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.†

WOMENS PLATINUM
calcarea carbonica, capsicum annuum, ferrum metallicum, glandula suprarenalis, graphites, hepar suis, hypothalamus, iodium, kali carbonicum, oophorinum, pancreatinum, phytolacca decandra, pulsatilla, sepia. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70965-002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70965-002-02	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/10/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/10/2016

Labeler - Breakthrough M2 Inc (039423774)

Registrant - OHM PHARMA INC. (030572478)

Name	Address	ID/FEI	Business Operations
Establishment
OHM PHARMA INC.		030572478	manufacture(70965-002)