OATMEAL: 76 Adverse Event Reports & Safety Profile
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Drug Class: Allergens [CS] · Route: TOPICAL · Manufacturer: Meijer, Inc. · HUMAN OTC DRUG · FDA Label: Available
First Report: 20141202 · Latest Report: 20240916
What Are the Most Common OATMEAL Side Effects?
All OATMEAL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| No adverse event | 26 | 34.2% | 0 | 0 |
| Drug ineffective | 25 | 32.9% | 0 | 0 |
| Rash | 6 | 7.9% | 0 | 0 |
| Application site rash | 5 | 6.6% | 0 | 0 |
| Pruritus | 5 | 6.6% | 0 | 1 |
Who Reports OATMEAL Side Effects? Age & Gender Data
Gender: 70.2% female, 29.8% male. Average age: 33.1 years. Most reports from: US. View detailed demographics →
Is OATMEAL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 1 |
| 2015 | 5 | 0 | 1 |
| 2016 | 2 | 0 | 0 |
| 2017 | 4 | 0 | 2 |
| 2018 | 7 | 0 | 3 |
| 2019 | 3 | 0 | 0 |
| 2020 | 4 | 0 | 3 |
| 2021 | 3 | 0 | 0 |
| 2022 | 1 | 0 | 1 |
| 2023 | 2 | 0 | 0 |
| 2024 | 4 | 0 | 1 |
What Is OATMEAL Used For?
| Indication | Reports |
|---|---|
| Eczema | 23 |
| Product used for unknown indication | 19 |
Other Drugs in Same Class: Allergens [CS]
Official FDA Label for OATMEAL
Official prescribing information from the FDA-approved drug label.
Drug Description
Description VASELINE CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM - (colloidal oatmeal) cream
FDA Approved Uses (Indications)
Directions *Wash affected area and dry thoroughly * Apply twice daily (morning and night) over the affected area , or as directed by a physician. * Use daily for 4 weeks, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily. * For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, change shoes and socks at least once daily. * For athlete's foot and ringworm, use daily for 4 weeks. * For jock itch, use daily for 2 weeks. * Supervise children in the use of this product. * This product is not proven to be effective on scalp or nails. * Wash hands after each use.
Dosage & Administration
Directions For dispersal in water: Turn warm water faucet on to full force. Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container. Stir any colloidal oatmeal settled on the bottom. For use as a soak in a bath: Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom. 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.
Known Adverse Reactions
disclaimer Enriched with soothing oatmeal, Walgreens Baby Eczema therapy Cream helps relieve dry, itchy skin while intensely moisturizing. The formula is enriched with ceramides, essential lipids naturally found in skin, to enhance skin's protective function. †Our pharmacists recomment the Walgreens brand. We invite you to compare to national brands. ††This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Aveeno Baby ® .
Warnings
Warnings Do not use :
- On severe burns or sunburned skin.
- If you are allergic to ingredients in this product. When using this product :
- Avoid contact with eyes.
- If contact occurs, rinse the eyes thoroughly with water.
- If using hydrocortisone, follow dosage instructions. Stop use and ask a doctor if :
- Rash appears.
- Condition worsens or does not improve in 2-4 weeks. If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Active Ingredient
Claims QUALITY GUARANTEED If for any reason you are not satisfied, we'll give you a full refund.
Active ingredient Colloidal oatmeal 1%
Inactive Ingredients
Water (Aqua), Helianthus Annuus (Sunflower)
Seed
Oil (1), Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Butyrospermum Parkii (Shea) Butter (1), Carthamus Tinctorius (Safflower)
Seed
Oil (1), Cocos Nucifera (Coconut) Oil (1), Beeswax (1), Cannabis Sativa Seed Oil, Citrus Aurantifolia (Lime) Oil, Citrus Aurantium Bergamia (Bergamot)
Fruit
Oil, Citrus Aurantium Dulcis (Orange)
Peel
Oil, Citrus Grandis (Grapefruit)
Peel
Oil, Citrus Limon (Lemon)
Peel
Oil, Citrus Nobilis (Mandarin Orange)
Peel
Oil, Eucalyptus Globulus Leaf Oil, Prunus Armeniaca (Apricot)
Kernal
Oil (1), Rosmarinus Officinalis (Rosemary)
Leaf
Oil, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Extract, Betula Alba Juice, Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria)
Flower
Extract (1), Citrus Aurantium Dulcis (Orange)
Fruit
Extract, Curcuma Longa (Turmeric)
Root
Powder (1), Mentha Citrata Leaf Extract, Rosa Centifolia Flower Extract, Rubus Fruticosus (Blackberry)
Fruit
Extract, Biotin, Tocopheryl Acetate, Citric Acid, Sodium Citrate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citral, Limonene, Linalool. (1)
Certified Organic
Ingredient