FDA.reportPublic FDA data

O'KEEFFE'S ECZEMA RELIEF HAND CREAM

Manufacturer
The Gorilla Glue Company/O'Keeffe's Company
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:15:43

Label at a glance#

ProductOKeeffes Working Hands Eczema Relief Cream
Active ingredientOATMEAL
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Colloidal oatmeal 2%

OTC - PURPOSE SECTION

Purpose

Skin protectant

INDICATIONS & USAGE SECTION

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes
  • eczema

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product do not get into eyes

OTC - STOP USE SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

apply as needed

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Glycerin, Cetyl Alcohol, Isopropyl Myristate, Dimethicone, Aluminum Starch Octylsuccinate, Cetearyl Alcohol, Ceteareth-20, Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Distearyldimonium Chloride, Panthenol, Allantoin, 1,2-Hexanediol, Caprylyl Glycol, Polyquaternium-10, Beeswax, Caesalpinia Spinosa Gum, Bisabolol, Disodium EDTA, Zingiber Officianale (Ginger) Root Extract, Glyceryl Stearate, PEG-100 Stearate, Laureth-4, Laureth-23, Laureth-12, Phenoxyethanol, Ethylhexyglycerin

SPL UNCLASSIFIED SECTION

OKeeffesCompany.com

Questions/Comments: 1-800-275-2718

©2021 Distributed by:

O'Keeffe's Company

Cincinnati, OH 45241

Made in USA with Domestic and Imported Materials

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O'KEEFFE'S®

WORKING HANDS CREAM

ECZEMA RELIEF

RELIEVES EXTREMELY DRY, CRACKED HANDS

Colloidal Oatmeal Skin Protectant

48 Hour Itch Relief

Dermatologist Tested

Steroid & Fragrance Free

GUARANTEED RELIEF

Net Wt. 2.0 oz. (57 g)

108706 Working Hands 2OZ108706 Working Hands 2OZ

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71564-007OKEEFFES WORKING HANDS ECZEMA RELIEF CREAM (COLLOIDAL OATMEAL) CREAM [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY]2Legacy NDC20240110_d889a37c-ae5a-1bdd-e053-2a95a90ac7b6.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71564-00771564-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAESALPINIA SPINOSA RESINWL3883U2POIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
LEVOMENOL24WE03BX2TIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURETH-46HQ855798JIACT
CAPRYLYL GLYCOL00YIU5438UIACT
LAURETH-12OAH19558U1IACT
YELLOW WAX2ZA36H0S2VIACT
PEG-100 STEARATEYD01N1999RIACT
LAURETH-23N72LMW566GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
EDETATE DISODIUM7FLD91C86KIACT
GINGERC5529G5JPQIACT
SHEA BUTTERK49155WL9YIACT
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
DIMETHICONE92RU3N3Y1OIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PANTHENOLWV9CM0O67ZIACT
OATMEAL8PI54V663YACTIB

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
44764550-54ad-869c-e063-6294a90a75afd889a37c-ae5a-1bdd-e053-2a95a90ac7b62025-11-25WarningsExact identifier
spl set id: d889a37c-ae5a-1bdd-e053-2a95a90ac7b6

Reported adverse events (FAERS/openFDA)#

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