FDA.reportPublic FDA data

PUTRIZEN 40 UREA - Shantou Ximonth Biotechnology Co., Ltd.

Manufacturer
Shantou Ximonth Biotechnology Co., Ltd.
Effective date
2026-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-04 05:10:17

Label at a glance#

ProductPUTRIZEN 40 UREA
Active ingredientBUTYROSPERMUM PARKII (SHEA) BUTTER, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
Label structure12 sections

Storage and handling

Store in a cool and dry place.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

BUTYROSPERMUM PARKII (SHEA) BUTTER、SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL、MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

OTC - PURPOSE SECTION

1. Helps soften thick, rough, and hardened skin. 2. Gently exfoliates dry, flaky, and uneven texture. 3. Helps improve the appearance of cracked heels and calluses. 4. Moisturizes deeply to leave skin feeling smoother and softer. 5. With salicylic acid, lactic acid, and ceramides to support smoother-looking skin.

OTC - WHEN USING SECTION

Use on feet, heels, elbows, knees, or other rough areas. Wash hands after use.

WARNINGS SECTION

For external use only. Avoid contact with eyes. Do not use on broken, irritated, or sensitive skin. Discontinue use if irritation or rash occurs. Keep out of reach of children. Do not swallow.

OTC - DO NOT USE SECTION

Do not use on broken, irritated, or sensitive skin.

OTC - STOP USE SECTION

Do not use on broken, irritated, or sensitive skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

STORAGE AND HANDLING SECTION

Store in a cool and dry place.

INACTIVE INGREDIENT SECTION

UREA、WATER、GLYCERIN、PROPYLENE GLYCOL、LACTIC ACID、CETEARYL ALCOHOL、CAPRYLIC/CAPRIC TRIGLYCERIDE、SALICYLIC ACID、GLYCERYL STEARATE、PEG-100 STEARATE、CERAMIDE COMPLEX、PHENOXYETHANOL、ETHYLHEXYLGLYCERIN、PANTHENOL、ALLANTOIN、BISABOLOL、CARBOMER、 SODIUM HYALURONATE、SODIUM HYDROXIDE

INDICATIONS & USAGE SECTION

Use on feet, heels, elbows, knees, or other rough areas. Wash hands after use.

DOSAGE & ADMINISTRATION SECTION

Use on feet, heels, elbows, knees, or other rough areas. Wash hands after use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84989-02584989-025-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERYL STEARATE230OU9XXE4IACT
PANTHENOLWV9CM0O67ZIACT
CARBOMER0A5MM307FCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YACTIB
GLYCERINPDC6A3C0OXIACT
LACTIC ACID33X04XA5ATIACT
CETEARYL ALCOHOL2DMT128M1SIACT
PEG-100 STEARATEYD01N1999RIACT
BISABOLOL24WE03BX2TIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SOY SPHINGOLIPIDSP491F5HP1UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MACTIB
UREA8W8T17847WIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ALLANTOIN344S277G0ZIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GACTIB
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZIACT

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
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
ndc (package): 84989-025-01
ndc (product): 84989-025
ndc11 (package): 84989002501
spl id: 533dadbc-6f21-d880-e063-6394a90a753f
spl set id: 533dadbc-6f20-d880-e063-6394a90a753f

Reported adverse events (FAERS/openFDA)#

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