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Aveeno Baby Eczema Therapy Moisturizing — v8

Aveeno Baby Eczema Therapy Moisturizing

4 Views

Version

Effective date

September 26, 2025

Original packager

Yes

Sections captured

Identifiers

Document ID: 3f740ee8-f0d9-a9d9-e063-6294a90a4806
Set ID: 2a028465-1dff-4ae7-abf6-7521c2784dd1
Application numbers: M016
Product NDCs: 69968-0404
Package NDCs: 69968-0404-1, 69968-0404-2, 69968-0404-5, 69968-0404-7
Original packager NDCs: —

Names & Manufacturers

Brand names: Aveeno Baby Eczema Therapy Moisturizing
Generic names: OATMEAL
Manufacturer names: Kenvue Brands LLC
Product types: HUMAN OTC DRUG

Substances & Pharmacology

Substance names: OATMEAL
Routes: TOPICAL
Pharmacologic class (PE): Cell-mediated Immunity [PE], Increased Histamine Release [PE]
Pharmacologic class (EPC): Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC]
Pharmacologic class (CS): Allergens [CS], Dietary Proteins [CS], Plant Proteins [CS]
Mechanism of action: —

Other identifiers

NUI: M0000728, M0006342, M0016962, N0000175629, N0000184306, N0000185016, N0000185371, N0000185375
RxCUI: 240651
UNII: 8PI54V663Y
UPC: 0381371152049

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Colloidal Oatmeal 1%

Dosage And Administration (1)

Sequence 1

Directions Apply as needed

Inactive Ingredient (1)

Sequence 1

Inactive ingredients Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Sodium Chloride, Avena Sativa (Oat) Kernel Extract

Indications And Usage (1)

Sequence 1

Uses Temporarily protects and helps relieve minor skin irritation and itching due to: Eczema Rashes

Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 206 g Tube Label RECOMMENDED BY PEDIATRICIANS & DERMATOLOGISTS Aveeno ® baby eczema therapy moisturizing cream colloidal oatmeal skin protectant + vitamin B5 clinically proven to relieve itchy, irritated skin due to eczema ACCEPTED e NATIONALECZEMA.ORG NATIONAL ECZEMA ASSOCIATION fragrance-free & steroid-free hypoallergenic NET WT. 7.3 OZ (206 g) Aveeno_1

Purpose (1)

Sequence 1

Purpose Skin protectant

Questions (1)

Sequence 1

Questions? 866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

Spl Product Data Elements (1)

Sequence 1

Aveeno Baby Eczema Therapy Moisturizing Oatmeal WATER GLYCERIN PANTHENOL DISTEARYLDIMONIUM CHLORIDE ISOPROPYL PALMITATE CETYL ALCOHOL DIMETHICONE OAT KERNEL OIL STEARETH-20 BENZALKONIUM CHLORIDE CERAMIDE NP SODIUM CHLORIDE OAT OATMEAL OATMEAL PETROLATUM

Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Distributed by: Kenvue Brands LLC. Summit, NJ 07901

Stop Use (1)

Sequence 1

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.

Storage And Handling (1)

Sequence 1

Other information To open, twist off cap and remove quality seal. Do not use if quality seal is broken. For use on mild to moderate eczema or as directed by a physician. Store at room temperature.

Warnings (1)

Sequence 1

Warnings For external use only. When using this product Do not get into eyes. 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.

When Using (1)

Sequence 1

When using this product Do not get into eyes.

OpenFDA raw payload

{'application_number': ['M016'],
 'brand_name': ['Aveeno Baby Eczema Therapy Moisturizing'],
 'generic_name': ['OATMEAL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Kenvue Brands LLC'],
 'nui': ['N0000185371',
         'N0000185375',
         'N0000175629',
         'N0000184306',
         'M0000728',
         'M0006342',
         'M0016962',
         'N0000185016'],
 'package_ndc': ['69968-0404-5',
                 '69968-0404-7',
                 '69968-0404-1',
                 '69968-0404-2'],
 'pharm_class_cs': ['Allergens [CS]',
                    'Dietary Proteins [CS]',
                    'Plant Proteins [CS]'],
 'pharm_class_epc': ['Non-Standardized Food Allergenic Extract [EPC]',
                     'Non-Standardized Plant Allergenic Extract [EPC]'],
 'pharm_class_pe': ['Increased Histamine Release [PE]',
                    'Cell-mediated Immunity [PE]'],
 'product_ndc': ['69968-0404'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['240651'],
 'spl_id': ['3f740ee8-f0d9-a9d9-e063-6294a90a4806'],
 'spl_set_id': ['2a028465-1dff-4ae7-abf6-7521c2784dd1'],
 'substance_name': ['OATMEAL'],
 'unii': ['8PI54V663Y'],
 'upc': ['0381371152049']}