FDA.reportPublic FDA data

OKeeffes Healthy Feet

Manufacturer
The Gorilla Glue Company/O'Keeffe's Company
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:55

Label at a glance#

ProductOKeeffes Healthy Feet
Active ingredientALLANTOIN, LIDOCAINE HYDROCHLORIDE
Label structure11 sections

Storage and handling

Other information Child-resistant packaging. Store with lid closed tightly.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Allantoin 0.5%

Lidodaine HCl 4%

OTC - PURPOSE SECTION

Purposes

Skin protectant

Topical analgesic

INDICATIONS & USAGE SECTION

Uses temporarily

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

WARNINGS SECTION

Warnings

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.

STORAGE AND HANDLING SECTION

Other information

Child-resistant packaging. Store with lid closed tightly.

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments?

1-800-275-2718

SPL UNCLASSIFIED SECTION

GUARANTEED RELIEF

GUARANTEE: If you are not fully satisfied, we will refund 100% of the purchase price. Please retain product and call 1-800-275-2718 for replacement product or refund.

FOOT REPRESENTATIVE PHOTOS: Before and after foot images from one use. Cream was used according to package directions.

O'Keeffe's Company.com

1-800-275-2718

©2021 Distributed by:

O'Keeffe's Company

Cincinnati, OH 45241

Made in the USA with Domestic and Imported Materials

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O'KEEFFE'S

FOR HEALTHY FEET

PAIN RELIEF CREAM

SKIN PROTECTANT

PAIN RELIEF

RELIEVES, SOOTHES & HYDRATES

INSTANT RELIEF from:

Pain

Itching

Irritation

Dryness

GUARANTEED RELIEF

2 IN 1 PAIN RELIEF & MOISTURIZER

PODIATRIST APPROVED

MAX STRENGTH 4% LIDOCAINE

COOLING PEPPERMINT OIL

Net Wt. 3 oz. (85 g)

109623 HF PAIN RELIEF109623 HF PAIN RELIEF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2594492allantoin 0.5 % / lidocaine HCl 4 % Topical CreamPSN2
2594492allantoin 5 MG/ML / lidocaine hydrochloride 40 MG/ML Topical CreamSCD2
2594492allantoin 0.5 % / lidocaine hydrochloride 4 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71564-006-03OKeeffes Healthy Feet85 g in 1 TUBECREAM852
71564-006-03OKeeffes Healthy Feet1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71564-006OKEEFFES HEALTHY FEET (ALLANTOIN, LIDOCAINE) CREAM [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY]2Current NDC, Legacy NDC, 2 package rows20240110_d73709db-3932-3c56-e053-2995a90a7d0a.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
71564-00671564-006-03

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

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 Healthy FeetALLANTOIN, LIDOCAINEThe Gorilla Glue Company/O'Keeffe's Companyd73709db-3932-3c56-e053-2995a90a7d0a2024-01-01WarningsExact identifier
ndc (package): 71564-006-03
ndc (product): 71564-006
ndc11 (package): 71564000603
spl id: 0e77166a-8f68-eb67-e063-6394a90a1f12
spl set id: d73709db-3932-3c56-e053-2995a90a7d0a

Reported adverse events (FAERS/openFDA)#

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