"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
(testosterone) Topical Solution
SECONDARY EXPOSURE TO TESTOSTERONE
- Virilization has been reported in children who were secondarily exposed to topical testosterone products [see WARNINGS AND PRECAUTIONS].
- Children should avoid contact with unwashed or unclothed application sites in men using AXIRON [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
- Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].
AXIRON (testosterone) topical solution is a clear, colorless, single phase solution containing 30 mg of testosterone in 1.5 mL of AXIRON solution for topical administration through the axilla. The active pharmacologic ingredient in AXIRON is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:
The inactive ingredients are ethanol, isopropyl alcohol, octisalate, and povidone.
Last reviewed on RxList: 2/6/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Axiron Information
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