FDA.reportPublic FDA data

Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream

Manufacturer
Kenvue Brands LLC
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:41

Label at a glance#

ProductAveeno Eczema Therapy Rescue Relief Treatment
Active ingredientOATMEAL
Label structure11 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema

Dosage and administration

Apply as needed

Storage and handling

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Other Information

STORAGE AND HANDLING SECTION

  • Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Isopropyl Palmitate, Butyrospermum Parkii (Shea) Butter, Isododecane, Vegetable Oil, Cetyl Alcohol, Sodium Hydroxide, Lactic Acid, Sodium Polyacrylate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil, Cetearyl Olivate, Carbomer, 1,2-Hexanediol, Sorbitan Olivate, Hydrogenated Vegetable Oil, Euphorbia Cerifera (Candelilla) Wax, Avena Sativa (Oat) Kernel Extract, Tropolone

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 150mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

Aveeno®

Eczema

Therapy

RESCUE RELIEF

TREATMENT

GEL CREAM

Colloidal Oatmeal Skin Protectant

Instantly soothes & cools

itchy, dry skin flare-ups

Clinically proven soothing relief

of itch, irritation, & dry skin

Developed with Eczema Consumers

STEROID & FRAGRANCE FREE

DERMATOLOGIST RECOMMENDED BRAND

2% COLLOIDAL OATMEAL AND SHEA BUTTER

5 fl oz (150mL)

Aveeno_1Aveeno_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN4
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD4
1189915colloidal oatmeal 2 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0802-1Aveeno Eczema Therapy Rescue Relief Treatment14 mL in 1 TUBECREAM144
69968-0802-2Aveeno Eczema Therapy Rescue Relief Treatment44 mL in 1 BOTTLE, PUMPCREAM444
69968-0802-5Aveeno Eczema Therapy Rescue Relief Treatment150 mL in 1 BOTTLE, PUMPCREAM1504
69968-0802-9Aveeno Eczema Therapy Rescue Relief Treatment14 mL in 1 TUBECREAM144
69968-0802-9Aveeno Eczema Therapy Rescue Relief Treatment12 in 1 CARTONCREAM124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0802AVEENO ECZEMA THERAPY RESCUE RELIEF TREATMENT (COLLOIDAL OATMEAL) CREAM [KENVUE BRANDS LLC]4Current NDC, 5 package rows20241215_f67e528a-b822-3f7a-e053-2995a90ae733.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-080269968-0802-2, 69968-0802-5, 69968-0802-1, 69968-0802-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROPOLONE7L6DL16P1TIACT
OAT KERNEL OIL3UVP41R77RIACT
SHEA BUTTERK49155WL9YIACT
CETYL ALCOHOL936JST6JCNIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETEARYL OLIVATE58B69Q84JOIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
SORBITAN OLIVATEMDL271E3GRIACT
WATER059QF0KO0RIACT
OATMEAL8PI54V663YACTIB
GLYCERINPDC6A3C0OXIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ISODODECANEA8289P68Y2IACT
SODIUM HYDROXIDE55X04QC32IIACT
LACTIC ACID33X04XA5ATIACT
CANDELILLA WAXWL0328HX19IACT
OATZ6J799EAJKIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Eczema Therapy Rescue Relief TreatmentCOLLOIDAL OATMEALKenvue Brands LLCf67e528a-b822-3f7a-e053-2995a90ae7332024-12-06WarningsExact identifier
ndc (package): 69968-0802-9
ndc (package): 69968-0802-1
ndc (package): 69968-0802-2
ndc (package): 69968-0802-5
ndc (product): 69968-0802
ndc11 (package): 69968080205
ndc11 (package): 69968080202
ndc11 (package): 69968080209
ndc11 (package): 69968080201
spl id: 289fbce6-d2af-88b7-e063-6394a90a8a7d
spl set id: f67e528a-b822-3f7a-e053-2995a90ae733

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.