FDA.reportPublic FDA data

HAND FOOT

Manufacturer
Shenzhen Xiaomai Manufacturing Co., Ltd.
Effective date
2024-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:26

Label at a glance#

ProductHAND FOOT
Active ingredientSALICYLIC ACID, 1,1-DIPHENYLUREA
Label structure13 sections

Indications and uses

Helps improve dry and rough skin on hands and feet, making skin healthier and more comfortable.

Dosage and administration

After your hands are clean and dry Take an appropriate amount of hand cream and apply it evenly on your hands, especially dry or rough areas. Massage gently until completely absorbed. Use once or twice a day, especially before bed, so the hand cream has enough time to work.

Storage and handling

Please store in a cool, dry place away from direct sunlight.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION


Urea10%
Salicylic Acid5%

Purpose

OTC - PURPOSE SECTION

Helps improve dry and rough skin on hands and feet, making skin healthier and more comfortable.

Uses

INDICATIONS & USAGE SECTION


Helps improve dry and rough skin on hands and feet, making skin healthier and more comfortable.

Warnings

WARNINGS SECTION


For external use only
Do not use Skin irritation or allergic reaction occurs.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children.If swallowed, get medical help or contacta Poison Control Center right away.

Do not use

DESCRIPTION SECTION


For external use only
Do not use Skin irritation or allergic reaction occurs.

When using this product

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Ask Doctor

OTC - ASK DOCTOR/PHARMACIST SECTION


Stop use and ask a doctor if rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION


After your hands are clean and dry
Take an appropriate amount of hand cream and apply it evenly on your hands, especially dry or rough areas.
Massage gently until completely absorbed.
Use once or twice a day, especially before bed, so the hand cream has enough time to work.

Other information

STORAGE AND HANDLING SECTION

Please store in a cool, dry place away from direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION


Aqua,Camellia Sinensis Leaf Extract,Cocos Nucifera (Coconut) Oil,Dodecane, Cetearyl Alcohol, Polysorbate 60,Glyceryl Stearate, PEG-100 Stearate,Cetyl Alcohol, Aloe Barbadensis Leaf Juice,Melaleuca Alternifolia (Tea Tree)Leaf Oil,Glycerin,Dipropylene Glycol, Carbomer,Xanthan Gum, Ethylhexylglycerin,Caprylyl Glycol,Butyrospermum Parkii (Shea) Oil, Hexylene Glycol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83872-265-01HAND FOOT50 g in 1 BOTTLECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83872-265HAND FOOT CREAM [SHENZHEN XIAOMAI MANUFACTURING CO., LTD.]11 package rows20240630_1bf1586b-127a-e8e4-e063-6394a90a122f.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83872-26583872-265-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DODECANE11A386X1QHIACT
POLYSORBATE 60CAL22UVI4MIACT
XANTHAN GUMTTV12P4NEEIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
COCONUT OILQ9L0O73W7LIACT
SALICYLIC ACIDO414PZ4LPZACTIB
CETYL ALCOHOL936JST6JCNIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
1,1-DIPHENYLUREAH33D27I551ACTIB
GLYCERYL STEARATE SEFCZ5MH785IIACT

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
1bf1586b-127b-e8e4-e063-6394a90a122f1bf1586b-127a-e8e4-e063-6394a90a122f2024-06-28WarningsExact identifier
spl id: 1bf1586b-127b-e8e4-e063-6394a90a122f
spl set id: 1bf1586b-127a-e8e4-e063-6394a90a122f

Reported adverse events (FAERS/openFDA)#

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