FDA.reportPublic FDA data

Hand Repair Cream

Manufacturer
Canadian Custom Packaging Company
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:41:58

Label at a glance#

ProductSKINFIX HAND REPAIR
Active ingredientOATMEAL
Label structure8 sections

Indications and uses

Temporarily protects dry cracked skin and helps relieve monor skin irritations and itching due to eczema.

Dosage and administration

Apply cream liberally as needed, especially after hand washing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Warnings

WARNINGS SECTION

For external use only.

When using this product Avoid contact with eyes.

Stop use and ask a doctor if condition worsens.

If 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.

Uses

INDICATIONS & USAGE SECTION

Temporarily protects dry cracked skin and helps relieve monor skin irritations and itching due to eczema.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply cream liberally as needed, especially after hand washing.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

allantoin, aloe barbadensis leaf juice, avena sativa kernel oil, beeswax, butyrospermum parkii (shea) butter, calendula officinalis extract, capyrlic/capric triglyceride, caprylyl-caprylate/caprate, chamomilla recutita (matricaria) flower extract, citric acid, ethylhexylglycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, oryza sativa (rice) bran extract, petrolatum, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, prunus amygdalus dulcis (sweet almond) oil, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, water (aqua), xanthan gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN4
240651colloidal oatmeal 10 MG/ML Topical CreamSCD4
240651Avena sativa 1 % Topical CreamSY4
240651colloidal oatmeal 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54291-035-01SKINFIX HAND REPAIR10 mL in 1 TUBECREAM104
54291-035-02SKINFIX HAND REPAIR90 mL in 1 TUBECREAM904
54291-035-03SKINFIX HAND REPAIR60 mL in 1 TUBECREAM604
54291-035-04SKINFIX HAND REPAIR30 mL in 1 TUBECREAM304
54291-035-05SKINFIX HAND REPAIR150 mL in 1 TUBECREAM1504
54291-035-06SKINFIX HAND REPAIR148 mL in 1 PACKAGECREAM1484

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54291-035SKINFIX HAND REPAIR (OATMEAL) CREAM [CANADIAN CUSTOM PACKAGING COMPANY]46 package rows20241212_60672feb-1425-651e-e053-2a91aa0af41d.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54291-03554291-035-02, 54291-035-03, 54291-035-04, 54291-035-01, 54291-035-05, 54291-035-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
OAT KERNEL OIL3UVP41R77RIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS WHOLEPFR03EBU0HIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL CAPRYLATE/CAPRATE22MCG4RSMRIACT
MATRICARIA CHAMOMILLA WHOLE2Z4LRR776SIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUNFLOWER OIL3W1JG795YIIACT
ORYZA SATIVA WHOLE84IVV0906ZIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-2 DIISOSTEARATEDG195GP57PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ROSMARINUS OFFICINALIS WHOLEEA3289138MIACT
JOJOBA OIL724GKU717MIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TOCOPHEROLR0ZB2556P8IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
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
28ef7ef8-7b8d-afff-e063-6394a90a9fa860672feb-1425-651e-e053-2a91aa0af41d2024-12-10WarningsExact identifier
spl id: 28ef7ef8-7b8d-afff-e063-6394a90a9fa8
spl set id: 60672feb-1425-651e-e053-2a91aa0af41d

Reported adverse events (FAERS/openFDA)#

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