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Allantoin is a skin protectant found in over-the-counter skin products that a pharmacy may also compound into topical creams when a prescriber orders it.
Allantoin is a small nitrogen-containing compound (an imidazolidine-2,4-dione) that occurs naturally as a human metabolite; ChEBI classes it as a vulnerary, meaning a wound-healing agent. It is one of the active ingredients listed in the FDA's over-the-counter (OTC) skin protectant monograph (21 CFR part 347, monograph M016). Skin protectants temporarily protect injured or exposed skin from harmful or annoying stimuli. Products such as Coats Aloe cream, marketed under that OTC monograph, are labeled to temporarily protect minor cuts, scrapes and burns, and to help prevent and protect chafed, chapped or cracked skin and skin exposed to wind and cold. A search of Drugs@FDA found no prescription allantoin product. A prescriber might order allantoin compounded in a cream base, strength or form that is not sold over the counter. Compounded preparations are not FDA-approved and require a prescription.
Allantoin OTC labels carry no boxed warning. Allantoin is for use on the skin only: keep it out of the eyes, and do not use it on deep or puncture wounds, animal bites or serious burns. Stop use and ask a doctor if the condition worsens, if symptoms last more than 7 days, or if they clear up and come back within a few days. If it is swallowed, get medical help or contact a poison control center right away. The cited label lists no drug interactions. The OTC label gives no pregnancy or breastfeeding statement and no LactMed record for allantoin was found, so ask before using it if you are pregnant or breastfeeding. A compounded preparation may contain other ingredients that carry their own warnings. If you notice a skin reaction or any other side effect, talk to your prescriber or pharmacist.
Allantoin is described by ChEBI as an imidazolidine-2,4-dione and a human metabolite with a vulnerary role. Mechanistic data are limited: in a rat open-wound model, an oil-in-water lotion containing allantoin was associated with regulation of the inflammatory response and stimulation of fibroblast proliferation and extracellular matrix synthesis (Araújo et al., Acta Cir Bras 2010); that study did not involve humans. Systemic pharmacokinetic data for topical allantoin were not found in the sources reviewed. Regulatory status: allantoin is a listed skin protectant active ingredient in 21 CFR 347.10 (OTC monograph M016), with labeling in 21 CFR 347.50 limited to temporary protection of minor cuts, scrapes and burns and of chafed, chapped or cracked skin, including protection from wind and cold. An openFDA Drugs@FDA query returned no NDA or ANDA for allantoin. Prescribers have ordered compounded allantoin in topical creams; IJPC has published a coal tar and allantoin cream formulation (Allen, 2007). Uses outside the monograph statements fall outside 21 CFR part 347; OTC monograph products are not individually FDA-approved. Dosing is per prescriber. Monitor the treated area for worsening or for symptoms lasting more than 7 days, per the monograph warnings, and for reactions to other ingredients in the base.
Compounded at Bayview
Patient guides for the preparations we make most often. Each one is compounded to order and requires a prescription.
We do not have a patient page for this ingredient yet. That does not mean we cannot make it. Bayview compounds this ingredient to a prescriber's order, and our full compounding formulary lists every preparation we make. Viewing the formulary requires a prescriber account.
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Every preparation in our formulary that contains this ingredient. Strength, base and dose form are set by the prescription.
Other salt forms of this molecule, and ingredients commonly compounded alongside it.
This page describes an active pharmaceutical ingredient, not a finished drug product. Bayview Pharmacy compounds preparations containing it only on a prescriber's order for an individual patient.
Compounded preparations are not FDA-approved, and the FDA has not evaluated them for safety, effectiveness, or manufacturing quality. Nothing on this page is a claim that any preparation is effective for any condition.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Our pharmacists work with prescribers to build preparations around a patient's dose, form and tolerances. Ask us what is possible with this ingredient.
