Aveeno Soothing Bath Treatment
Aveeno Soothing Bath Treatment is an FDA drug label for the active ingredient OATMEAL manufactured by Kenvue Brands LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260721.
- Generic name
- OATMEAL
- Manufacturer
- Kenvue Brands LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 69968-0405
- Application
- M016
- Label effective
- 20260721
About this product
Aveeno Soothing Bath Treatment is an FDA-registered drug product whose active ingredient is OATMEAL. It is labelled by Kenvue Brands LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 69968-0405, application M016, label effective 20260721. It is one of 12 FDA drug label records sharing the active ingredient OATMEAL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing OATMEAL are most often described in connection with: temporarily protects, helps relieve, minor skin, itching due, rashes eczema, poison ivy, oak sumac, insect bites. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses Temporarily protects and helps relieve minor skin irritation and itching due to Rashes Eczema Poison ivy, oak or sumac Insect bites
Dosage & Administration
Directions Turn warm water faucet on to full force Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tube or container Stir any colloidal oatmeal settled on the bottom For use as a soak in a bath: soak affected area for 15 to 30 minutes as needed, or as directed by a doctor pat dry (do not rub) to keep a thin layer on the skin.
Warnings
Warnings For external use only. When using this product Do not get into eyes To avoid slipping, use mat in tub or shower In some skin conditions, soaking too long may overdry Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
More products with the same ingredient
OATMEALDERMA SANTE Anti Eczema Cream
View labelDERMOIA Manuka Honey Eczema Cream
View labelDerma-e Eczema Relief
View labelDermoia Eczema Relief Colloidal Oatmeal
View labelLa Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief
View labelLa Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief
View labelM3 NATURALS Eczema Cream
View labelHow products containing OATMEAL compare
FDA lists 12 drug label records with OATMEAL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | THERAPLEX, LLC | 2 |
| — | — | COSMETIQUE ACTIVE PRODUCTION | 1 |
| — | — | DrAnaMaria. Com LLC | 1 |
| — | — | Hope Science Inc. | 1 |
| — | — | Kenvue Brands LLC | 1 |
Recall and safety notices
1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0121-2026 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. | Kenvue Brands LLC | Class II | Ongoing | 20251105 |
Frequently asked questions
What is Aveeno Soothing Bath Treatment used for?
Uses Temporarily protects and helps relieve minor skin irritation and itching due to Rashes Eczema Poison ivy, oak or sumac Insect bites
Who makes Aveeno Soothing Bath Treatment?
Kenvue Brands LLC is the labeler of record for Aveeno Soothing Bath Treatment. 12 FDA label records share the active ingredient OATMEAL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Aveeno Soothing Bath Treatment come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Aveeno Soothing Bath Treatment prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing OATMEAL?
Yes. 12 FDA drug label records list OATMEAL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Aveeno Soothing Bath Treatment been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.