Womens Platinum
FDA Label NDC 70965-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Breakthrough M2 Inc for the product Womens Platinum (NDC 70965-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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.

Purpose

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

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 breast-feeding or taking any medication, ask a healthcare professional before use.
  • Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800-222-1222).

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions

Use only as directed. 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 broken or missing.
  • **These statements are based upon traditional homeopathic practice. They have not been evaluated by the Food & Drug Administration.
  • *The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
  • Made in USA in FDA inspected facility.

Inactive Ingredient

Inactive ingredients

Ethyl Alcohol, Purified Water

Otc - Purpose

Homeopathic Weight Management Support**

Package Label.Principal Display Panel

NDC 70965-002-02

Breakthrough M2

Weight Loss & Transformation

Homeopathic Women's PLATINUM

Body, Mind, & Spirit

Homeopathic Weight Management Support**

2 fl oz (59 ml)

Alcohol 20%

* Please review the disclaimer below.