Otc - Active Ingredient
ACTIVE INGREDIENTS- Equal Amounts Of:
Agnus Castus 3X
Angelica Sin 3X
Apis Mel 6X
Cimicifuga Rac 3X
Estradiol 9C
Estriol 9C
Folliculinum 9C
Galium 3X
Glycyrrhiza 3X
Oophorinum 30C
Progesterone 6X
Sepia 30C
Estropro Spray
FDA Label NDC 43853-0038
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 Estropro (NDC 43853-0038). 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, otc - purpose, indications & usage, warnings, keep out of reach of children, pregnant or breast feeding, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
| Agnus Castus, Angelica Sin, Apis Mel, Cimicifuga Rac, Estradiol, Estriol, Folliculinum, Galium, Glycyrrhiza, Oophorinum, Progesterone, Sepia | To rebalance estrogen and progesterone output |
Indications & Usage
Uses: Temporarily supports the body to rebalance estrogen and progesterone output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings
Warnings:
Not for use on children. If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Pregnant Or Breast Feeding
As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.
Dosage & Administration
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 Ingredient
Inactive Ingredients: Organic Ethanol 20%, Purified water.
Other
Distributed By: ProBLEN (888) 326-2121
3021 Ridge Rd., Rockwall, TX 75032
Storage And Handling
Other Information: Store at room temperature.
Tamper Evident: There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.
Otc - Questions
Questions or Comments: www.problen.com
Principal Display Panel
Label (Estropro)
* Please review the disclaimer below.
