Testosterone
FDA Label NDC 43853-0005

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 Testosterone (NDC 43853-0005). 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:

Avena Sativa 1X, Carduus Marianus 1X, Damiana 1X, Galium Aparine 3X, Hamamelis Virginiana 1X, Hepar Bovine 6X, Korean Ginseng 1X, Nuphar Luteum 2X, Orchitinum (Bovine) 6X, Populus Tremuloides 1X, Testosterone 30X, Thuja Occidentalis 200C.

Indications:

Temporarily supports the body to rebalance testosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

Temporarily supports the body to rebalance testosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

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:

Purified Water, Organic Ethanol 30%

Questions:

Distributed By ProBLEN

2850 Shoreline Trail

Rockwall, TX 75032

www.problen.com

Package Label Display:

Testosterone

HOMEOPATHIC

ORGANOTHERAPY

1.0 FL OZ (30 ML)

proBLEN

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