Prescription only
Testosterone Gel
Sold as AndroGel 1%, AndroGel 1.62%, Vogelxo, Testim.
What the label states
BOXED WARNING — SECONDARY EXPOSURE TO TESTOSTERONE, quoted from the AndroGel label with its section cross-references removed: “Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.” Note who the box names: children. Women appear elsewhere in the same label — the administration instructions read “Children and women should avoid contact with unwashed or unclothed application site(s) of men using AndroGel 1.62%” — but the boxed warning itself is about children. Only after that, the dose, and it is not one number: “The recommended starting dose of AndroGel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets or one 50 mg packet), applied topically once daily in the morning”, adjustable to 75 mg or 100 mg; while “The recommended starting dose of AndroGel 1.62% is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet)”, adjustable between 20.25 mg and 81 mg. Each label adds that its “application site and dose… are not substitutable with other topical testosterone products.”
Quoted from the approved product label. Clinics commonly prescribe differently — more frequent, smaller injections of the same weekly total are routine — and where this site describes that, it is named as practice rather than as labelling.
- Route
- Topical, once daily in the morning, to clean, dry, intact skin — and the permitted site is product-specific. AndroGel 1% goes on the shoulders, upper arms and/or abdomen; AndroGel 1.62% goes on the shoulders and upper arms only.
- Vehicle
- A hydroalcoholic gel, not an oil. AndroGel 1% is carbomer 980, ethanol 67.0%, isopropyl myristate, purified water and sodium hydroxide. The alcohol content is why every label warns to “Avoid fire, flames or smoking until the gel has dried”.
- Usual barrel
- None — this compound is not drawn into a syringe
- Strengths covered
- No strength page yet
Why there is no syringe
There is no syringe, no needle, no barrel and no unit conversion, and saying so is more useful than the nearest plausible answer. Testosterone gel is pumped or squeezed into the palm and spread across the skin; the number that matters is milligrams per pump actuation, and it is not the same number on every product — one press of an AndroGel 1% pump delivers 12.5 mg, one press of an AndroGel 1.62% pump delivers 20.25 mg. That is the conversion to get right here, and it is a 62% difference in the same gesture with the same-looking device. If you have arrived from a page about drawing testosterone into a barrel, none of that arithmetic applies: there is no vial, no concentration in mg/mL to divide by, and no insulin units. The practical measurement discipline for a gel is priming the pump three times before the first dose and discarding that gel, then counting actuations.
Administration
- 1
Read the boxed warning before the dose
Virilisation has been reported in children secondarily exposed to testosterone gel: enlargement of the penis or clitoris, pubic hair, increased erections and libido, aggressive behaviour, advanced bone age. Most regressed when exposure stopped. In a few cases enlarged genitalia did not fully return to age-appropriate size and bone age stayed ahead of chronological age. The transfer risk was higher in some of those cases because the application instructions were not followed.
- 2
Confirm the diagnosis first
As with every testosterone product: serum testosterone measured in the morning on at least two separate days, both below the normal range, before therapy is initiated.
- 3
Check which product you have, then apply only where its label says
AndroGel 1%: shoulders and upper arms and/or abdomen, and “Do not apply AndroGel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back.” AndroGel 1.62%: shoulders and upper arms only, and “Do not apply AndroGel 1.62% to any other parts of the body including the abdomen, genitals, chest, armpits (axillae), or knees.” The abdomen is permitted on one and prohibited on the other. Keep the area within what a short-sleeved t-shirt covers.
- 4
Prime a new pump three times and throw that gel away
The label is specific: with the canister upright, slowly and fully depress the actuator three times and safely discard the gel from the first three actuations. Priming is needed only before the first dose. After that, count actuations — 12.5 mg each on AndroGel 1%, 20.25 mg each on AndroGel 1.62%.
- 5
Let it dry, then cover it
Allow the site to dry, then cover it with clothing. Until it has dried, avoid fire, flames and smoking — these are alcohol-based products and they are flammable.
- 6
Wash your hands immediately
Soap and water, straight after applying. Hands are the most likely route by which the drug reaches someone it was not prescribed for.
- 7
Wash the site before skin-to-skin contact
The label’s own precaution: “Prior to situations in which direct skin-to-skin contact is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.” If unwashed treated skin does touch someone else, wash the area of contact on the other person with soap and water as soon as possible.
- 8
Respect the wait before water
And check which product you have, because the interval differs: at least 5 hours before swimming or showering on AndroGel 1%, a minimum of 2 hours on AndroGel 1.62%.
- 9
Discard used pumps and packets where children and pets cannot reach them
The label directs discarding used pumps and packets in household trash “in a manner that prevents accidental application or ingestion by children or pets”. A spent packet still holds drug.
Storage
- —Store at controlled room temperature 20–25 °C (68–77 °F); excursions permitted to 15–30 °C (59–86 °F).
- —Keep away from fire and flame — these are alcohol-based gels and the label calls them flammable.
- —A metered-dose 88 g AndroGel 1.62% pump dispenses 75 g of gel, or 60 actuations of 1.25 g each. Count actuations rather than estimating what is left by weight.
- —Dispose of used pumps and packets so that children and pets cannot reach the residue.
Monitoring
| Marker | When | Why |
|---|---|---|
| Signs of secondary exposure in the household | Continuously, for as long as anyone is using the gel | The one item on this table that is not about the patient. In children: unexpected sexual development, enlargement of the penis or clitoris, premature pubic hair, increased erections, aggressive behaviour. In women: changes in hair distribution, increased acne, other signs of testosterone effect. The label directs that the gel “should be promptly discontinued until the cause of virilization has been identified.” |
| Total testosterone | AndroGel 1.62%: pre-dose, in the morning, at about 14 days and 28 days after starting or adjusting. AndroGel 1%: at intervals, as directed | The 1.62% label titrates in 20.25 mg steps against a 350–750 ng/dL pre-dose window. The 1% label is looser — increase from 50 mg to 75 mg to 100 mg if the level is below range, and discontinue if the level consistently exceeds the normal range at 50 mg daily. Two products, two titration rules. |
| Haematocrit | Baseline and periodically | Erythrocytosis occurs with topical testosterone as with injected, and may call for a dose reduction or stopping. |
| PSA and prostate symptoms | Baseline and periodically in men over 40 | Standard across testosterone products; the Endocrine Society guideline sets out baseline risk stratification. |
| Blood pressure | Periodically | Testosterone can raise blood pressure, and testosterone products are not recommended in uncontrolled hypertension. |
Frequently asked questions
- What exactly does the testosterone gel boxed warning say?
- Verbatim, with the label’s section cross-references removed: “WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.” It is worth reading the subject line carefully: the box is about children. Women are covered by the same label but in different sections — Warnings and Precautions 5.1, the administration instructions and Patient Counseling 17.2, all of which read “Children and women should avoid contact with unwashed or unclothed application site(s)”. Sources that describe the boxed warning as covering women and children are compressing two parts of the label into one.
- Can I switch from AndroGel 1% to AndroGel 1.62% at the same milligrams?
- No, and each label forecloses it: “The application site and dose of AndroGel 1.62% are not substitutable with other topical testosterone products,” with the mirror sentence on the 1% label. The two differ in almost everything a switch would need to hold constant. Starting dose: 50 mg versus 40.5 mg. Milligrams per pump press: 12.5 versus 20.25. Permitted sites: the abdomen is allowed on 1% and explicitly prohibited on 1.62%. Titration: a 50/75/100 mg ladder against “the normal range” versus 20.25 mg steps against a 350–750 ng/dL pre-dose window. Wait before water: 5 hours versus 2 hours. Even the labels tell you to consult the other label rather than reason across.
- How many milligrams is one pump of testosterone gel?
- It depends on the product, and this is the conversion most worth getting right. One complete actuation of an AndroGel 1% pump delivers 12.5 mg of testosterone, so the 50 mg starting dose is four presses. One complete actuation of an AndroGel 1.62% pump delivers 20.25 mg in 1.25 g of gel, so the 40.5 mg starting dose is two presses. Same gesture, same-looking canister, 62% more drug per press on the higher-concentration product. A new pump must also be primed with three actuations that are discarded before the first real dose.
- Does every testosterone gel carry the secondary exposure boxed warning?
- Every topical one we checked does — AndroGel 1%, AndroGel 1.62%, Vogelxo and the Encube generic testosterone gel 1% all carry the identical WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. The instructive exception is a product that is a gel but is not topical: NATESTO is a testosterone nasal gel, applied inside the nostrils, and its label carries no boxed warning section at all. The warning attaches to treated skin that another person can touch, not to the word “gel”.
- How long do I have to wait before showering or swimming?
- Check your own carton, because the two AndroGel concentrations give different answers. AndroGel 1%: “The patient should be advised to avoid swimming or showering for at least 5 hours after the application.” AndroGel 1.62%: “The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application.” Neither figure transfers to the other product, and neither replaces the separate instruction to wash the site thoroughly before anticipated skin-to-skin contact.
- Does this page tell me what dose to use?
- No. It quotes what the labels state and flags where two products of the same molecule disagree. Starting dose, titration and whether a topical is the right route at all are decisions that need two low morning testosterone results and a clinician reading your levels on the schedule your specific product specifies.
Sources
- [1]FDA label — ANDROGEL (testosterone gel) 1.62% for topical use, ASCEND Therapeutics U.S., LLC. DailyMed SPL version 130, effective 2025-10-22, marketing category NDA (NDA022309)
- [2]FDA label — ANDROGEL (testosterone gel) 1% for topical use, ASCEND Therapeutics U.S., LLC. DailyMed SPL version 140, effective 2025-07-31, marketing category NDA (NDA021015)
- [3]FDA label — VOGELXO (testosterone) gel, for topical use, Upsher-Smith Laboratories, LLC. DailyMed SPL version 13, effective 2025-07-14, marketing category NDA (NDA204399) — cited for the identical boxed warning
- [4]FDA label — NATESTO (testosterone) nasal gel, Aytu BioScience, Inc. DailyMed SPL version 2, effective 2019-12-19, marketing category NDA (NDA205488) — cited only as the gel that carries no boxed warning
- [5]Bhasin S, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715–1744
Related
Educational reference, not medical advice. Dose, route and whether this compound is appropriate at all are decisions for your clinician.