FDA.reportPublic FDA data

O’Keeffe’s Working Hands Pain Relief Cream Skin Protectant

Manufacturer
The Gorilla Glue Company/O'Keeffe's Company
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:49

Label at a glance#

ProductOKeeffes Working Hands Pain Relief Skin Protectant
Active ingredientALLANTOIN, LIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves pain and itching associated with minor skin irritations protects and helps relieve chapped or cracked skin

Dosage and administration

adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients . . . . . . . . . . . . . Purposes

Allantoin 0.5% . . . . . . . . . . . . . . . . Skin protectant

Lidocaine HCl 4% . . . . . . . . . . . . . Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily

  • relieves pain and itching associated with minor skin irritations
  • protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas.
  • on deep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

When using this product avoid contact with 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 - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

  • adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • children under 12 years of age: consult a doctor.

Other information

OTHER SAFETY INFORMATION

Child-resistant packaging. Store with lid closed tightly.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Starch Octenylsuccinate, Beeswax, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, 1,2 Hexanediol, Isopropyl Myristate, Laureth-12, PEG-100 Stearate, Peppermint (Mentha Piperita) Oil, Phenoxyethanol, Polysilicone-11, Shea (Butyrospermum Parkii) Butter, Sodium Hydroxide, Water, Xanthan Gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-275-2718

SPL UNCLASSIFIED SECTION

O'KEEFFE'S ® WORKING HANDS ®

PAIN RELIEF CREAM SKIN PROTECTANT

PAIN RELIEF

RELIEVES, SOOTHES & HYDRATES

INSTANT RELIEF from:

Pain

Itching Irritation

Dryness

2 IN 1 PAIN RELIEF & MOISTURIZER

MAX STRENGTH † 4% LIDOCAINE

COOLING PEPPERMINT OIL

CLINICALLY PROVEN

RELIEVES

SOOTHES

HYDRATES

PROTECTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OKEEFFE'S ® WORKING HANDS ®

PAIN RELIEF CREAM SKIN PROTECTANT

Net Wt. 3 oz (85 g)

OKeeffesCompany.com

1-800-275-2718

©2023 Distributed by:

O'Keeffe's Company

Cincinnati, OH 45241

Made in USA with Domestic and Imported Materials

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2594492allantoin 0.5 % / lidocaine HCl 4 % Topical CreamPSN3
2594492allantoin 5 MG/ML / lidocaine hydrochloride 40 MG/ML Topical CreamSCD3
2594492allantoin 0.5 % / lidocaine hydrochloride 4 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71564-009-03OKeeffes Working Hands Pain ReliefSkin Protectant85 g in 1 TUBECREAM853
71564-009-03OKeeffes Working Hands Pain ReliefSkin Protectant1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71564-009OKEEFFES WORKING HANDS PAIN RELIEF SKIN PROTECTANT (ALLANTOIN, LIDOCAINE HYDROCHLORIDE) CREAM [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY]3Current NDC, 2 package rows20250130_0685da25-c9fa-e1cd-e063-6394a90ae1b3.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71564-00971564-009-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
1,2-HEXANEDIOLTR046Y3K1GIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERYL 1-STEARATE258491E1RZIACT
PEPPERMINT OILAV092KU4JHIACT
SHEA BUTTERK49155WL9YIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
LAURETH-12OAH19558U1IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DODECAMETHYLPENTASILOXANE0QDQ2VQ5YJIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALLANTOIN344S277G0ZACTIB
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
PEG-100 STEARATEYD01N1999RIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
WHITE WAX7G1J5DA97FIACT
WATER059QF0KO0RIACT

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
OKeeffes Working Hands Pain Relief Skin ProtectantALLANTOIN, LIDOCAINE HYDROCHLORIDEThe Gorilla Glue Company/O'Keeffe's Company0685da25-c9fa-e1cd-e063-6394a90ae1b32025-01-01WarningsExact identifier
ndc (package): 71564-009-03
ndc (product): 71564-009
ndc11 (package): 71564000903
spl id: 2cca0907-5d70-e478-e063-6294a90ad19d
spl set id: 0685da25-c9fa-e1cd-e063-6394a90ae1b3