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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated October 23, 2018

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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

    Uses:

    Temporarily gives support during weight management program.†

  • 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).

    ​KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    ​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

    Inactive ingredients:

    Ethyl Alcohol, Purified Water

  • QUESTIONS

    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.

  • PRINCIPAL DISPLAY PANEL

    NDC 70965-002-02

    Breakthrough

    M2

    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.†

  • 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. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70965-002
    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
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE6 [hp_X]  in 59 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE6 [hp_X]  in 59 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY8 [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
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70965-002-0259 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(70965-002)
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