FDA

The US Food and Drug Administration regulates medicines, over-the-counter (OTC) drugs, food labelling and medical devices. It matters for toddler eczema in three ways. It sets the rules for what OTC creams may claim, it puts safety warnings on prescription creams, and it decides the youngest age at which new drugs are licensed. US labels are widely read by parents outside the US, so FDA decisions shape Steroid Phobia and TCI avoidance well beyond America. Most non-prescription eczema products go through the OTC monograph system, not individual approval. A monograph sets the permitted active ingredients, uses, doses and labelling under which a product is “generally recognized as safe and effective” (GRASE). The CARES Act of 27 March 2020 modernised this system. It added section 505G to the FD&C Act and lets the FDA change monographs by administrative order instead of full rulemaking (FDA, OTC Monograph Reform page).

FDA [regulates] Hydrocortisone FDA [regulates] Colloidal Oatmeal FDA [relates] Steroid Phobia

OTC monographs: hydrocortisone and colloidal oatmeal. Under OTC monograph M017 (2023), Hydrocortisone 0.25–1% can be sold without prescription. The label must say “children under 2 years of age: do not use, consult a doctor” and “do not use for the treatment of diaper rash” (Nappy Rash). Stronger 2.5% is prescription-only (FDA M017). Under the Skin Protectant monograph, Colloidal Oatmeal is one of only two allowed actives, with hydrocortisone, that a US moisturiser may use to claim relief of eczema itch. The permitted claim is “temporary skin protection and relief of minor skin irritations and itching due to eczema” (Hebert 2020). The claim covers symptoms only, not treatment of Atopic Dermatitis. Under M017, a US toddler under 2 cannot be given OTC hydrocortisone without a doctor, even though UK and US guidelines use mild steroid on the face and nappy area under clinical direction.

Conflict: [FDA OTC Monograph M017, 2023] requires OTC hydrocortisone labels to say “do not use for the treatment of diaper rash”. [NICE CG57, 2007/2023] and [AFP, 2009] recommend mild steroid for the child’s face, neck and nappy area. Already logged in Hydrocortisone — unresolved; see open_questions.

FDA [regulates] Nappy Rash Hydrocortisone [treats] Atopic Dermatitis

Boxed warning on topical calcineurin inhibitors. The FDA approved topical Tacrolimus in 2000 and Pimecrolimus in 2001 as second-line treatments for children aged 2 and over. In 2006 it added a boxed (“black box”) warning about a possible lymphoma and skin-cancer risk. The warning was based mainly on case reports, transplant data and animal studies. Later evidence has not shown a cancer excess. This includes the PEER Registry (Margolis, JAMA Dermatol 2015), a 2023 meta-analysis of 3.4 million patients (Devasenapathy, Lancet Child Adolesc Health) and Arcuri (JAAD Int 2026). Health Canada removed its equivalent warning in 2019/2021, and UK SmPCs dropped cancer from the adverse-effects section in 2022. The US warning remains in 2026 and is linked to parents avoiding Topical Calcineurin Inhibitors. The FDA has issued no safety communication on Topical Steroid Withdrawal. The 2021 regulatory action on TSW came from the UK MHRA.

Conflict: [FDA boxed warning, 2006; still on US labels 2026] warns of a possible lymphoma and skin-cancer risk with TCIs. [Margolis/PEER, 2015], [Devasenapathy, 2023] and [Arcuri, 2026] find no increased cancer risk. Already logged in Topical Calcineurin Inhibitors — unresolved; see open_questions.

FDA [regulates] Topical Calcineurin Inhibitors PEER Registry [contradicts] FDA FDA [relates] Topical Steroid Withdrawal

Paediatric approvals of new drugs. The FDA is often the first, and the broadest, regulator to license newer eczema drugs for young children:

• Crisaborole (Eucrisa, PDE4 ointment) was first approved on 14 December 2016 and extended to mild-to-moderate AD from 3 months on 23 March 2020 (Drugs@FDA NDA 207695). The efficacy trials enrolled patients aged 2 and over.
• Dupilumab (Dupixent) covers moderate-to-severe AD from 6 months. The supplement for this age group was approved on 7 June 2022 (Drugs@FDA; label 2026).
• Ruxolitinib Cream (Opzelura 1.5%) was extended on 18 September 2025 to short-term, non-continuous use for mild-to-moderate AD in non-immunocompromised children aged 2–11, based on TRuE-AD3. Children may use at most one 60 g tube per 2 weeks on ≤20% of body surface area.
• In September 2021, after the ORAL Surveillance trial, the FDA required class boxed warnings on JAK Inhibitors: serious infection, death, cancer, major cardiac events and thrombosis. These warnings also appear on the ruxolitinib cream label. Oral abrocitinib and upadacitinib are licensed only from age 12, for refractory disease. Baricitinib has no US eczema indication.

Other FDA actions relevant to toddlers: a 2023 warning about severe infections in premature infants given Probiotics; listing shea as a tree nut for food-allergen labelling in 2006 and removing it in 2025 (Shea Butter, Tree Nut Allergy); and approval of the T.R.U.E. Patch Testing panel for ages 6–17 only, with no commercial panel indicated under 6.

FDA [regulates] Dupilumab FDA [regulates] Crisaborole FDA [regulates] Ruxolitinib Cream FDA [regulates] JAK Inhibitors FDA [regulates] Probiotics

FDA versus Europe. For the same drugs, FDA labels are usually broader than the European Medicines Agency’s for young children. Dupilumab covers moderate-to-severe AD from 6 months in the US but severe AD only in the EU. Crisaborole is licensed from 3 months in the US, but its EU licence was withdrawn unmarketed. Ruxolitinib cream is licensed from age 2 in the US but for adults only in the EU. The main exception is oral baricitinib: the EU licenses it from age 2 for AD, while the US label has no AD indication. These splits are logged as conflicts in Dupilumab, Crisaborole and JAK Inhibitors. They reflect regulatory and commercial choices, not new safety findings.

FDA [contradicts] European Medicines Agency

Licensing update (Oct 2026). These are the US paediatric eczema licences relevant to 1–4-year-olds, checked against current openFDA labels:

• Roflumilast Cream (Zoryve): 0.05% approved on 6 October 2025 for mild-to-moderate AD in ages 2–5; 0.15% remains for ages 6 and over. An application for infants aged 3–24 months is under review, with a decision due by 23 February 2027.
• Tapinarof Cream (Vtama): AD indication from age 2, efficacy supplement approved on 12 December 2024.
• Ruxolitinib Cream: still licensed from age 2 (label June 2026).
• Dupilumab: still licensed from 6 months (label April 2026).
• Tralokinumab, lebrikizumab and nemolizumab: still licensed from age 12 only.

None of the new creams carries a US licence below 2 years. Crisaborole (from 3 months) remains the only non-steroid topical licensed that young.

FDA [regulates] Roflumilast Cream FDA [regulates] Tapinarof Cream

Connections

• Topical Calcineurin Inhibitors — boxed cancer warning since 2006, source: Lam JAMA Dermatol 2021; Tham 2023
• Topical Steroid Withdrawal — no TSW safety communication found in round 3 searches (2021 action was MHRA), source: search 2026-10-03
• Colloidal Oatmeal — OTC Skin Protectant monograph permits eczema itch-relief claim, source: Hebert 2020
• Dupilumab — US licence from 6 months (moderate-to-severe), supplement approved 2022-06-07, source: Drugs@FDA / FDA label 2026
• JAK Inhibitors — 2021 class boxed warning; ruxolitinib cream ≥2 y (Sept 2025), source: FDA DSC 2021; Opzelura label
• Crisaborole — infant (≥3 months) extension approved 2020-03-23, source: Drugs@FDA
• Probiotics — 2023 warning on severe infections in premature infants given probiotics, source: NCCIH
• Hydrocortisone — OTC monograph M017: 0.25–1%, not under 2 years, not for diaper rash, source: FDA M017 2023
• Tacrolimus — approved 2000 for ages ≥2, source: Tham 2023
• Pimecrolimus — approved 2001 for ages ≥2, source: FDA label via Pimecrolimus note
• PEER Registry — key evidence against the boxed warning, source: Margolis 2015
• Ruxolitinib Cream — 2–11 y approval 18 Sept 2025, source: Opzelura label 2026
• Nappy Rash — OTC hydrocortisone label excludes diaper rash, source: FDA M017
• Shea Butter — tree-nut labelling 2006, removed 2025, source: Allergic Living
• Patch Testing — T.R.U.E. Test approved ages 6–17; none under 6, source: Patch Testing note
• MHRA — UK counterpart; issued the 2021 TSW action, source: Topical Steroid Withdrawal note
• European Medicines Agency — EU counterpart; narrower paediatric labels, source: EMA EPARs
• Steroid Phobia — US warnings feed parent fear of TCIs/steroids, source: vault synthesis
• Petrolatum — OTC skin-protectant active ingredient, source: Divya 2024
• Roflumilast Cream — 0.05% for 2–5 y approved 6 Oct 2025; infant sNDA pending, source: FDA ZORYVE label 2026
• Tapinarof Cream — AD ≥2 y approved 12 Dec 2024, source: Drugs@FDA; FDA VTAMA label 2025