Estrogen And Progesterone Spray
FDA Label NDC 43853-0017

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Problen for the product Estrogen And Progesterone (NDC 43853-0017). 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 active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Agnus Castus 3X, Angelica Sinensis 3X, Apis Mellifica 6X, Arnica Montana 6X, Cimicifuga Racemosa 3X, Estradiol 9C, Estriol 9C, Folliculinum 9C, Galium Aparine 3X, Glycyrrhiza Glabra 3X, Korean Ginseng 3X, Oophorinum (Suis) 30C, Progesterone 6X, Sepia 30C, Thuja Occidentalis 6X, Viscum Album 3X

Indications:

Temporarily supports the body to rebalance estrogen output.  Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

Temporarily supports the body to rebalance estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

Warnings:

Not for use on children.

If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness.

As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Tamper Evident. There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.

Keep Out Of Reach Of Children:

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.

Inactive Ingredients:

Organic Alcohol 30% v/v, Purified Water

Questions:

Distributed By ProBLEN
2850 Shoreline Trail,
Rockwall, TX 75032
www.problen.com

Package Label Display:

HOMEOPATHIC

ORGANOTHERAPY

Estro

gen

&

Progesterone

1.0 FL. OZ. (30ML)

proBLEN

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