FDA.reportPublic FDA data

DERMFREE Anti-itch

Manufacturer
Jiangxi Hemei Pharmaceutical Co., Ltd
Effective date
2025-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:39:35

Label at a glance#

ProductDERMFREE Anti-itch
Active ingredientHYDROCORTISONE ACETATE
Label structure12 sections

Dosage and administration

▇do not use more than directed ▇adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ▇children under 2 years of age: ask a doctor

Storage and handling

▇protect from excessive heat (40°C/104°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone acetate 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Use

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching associated with:

▇insect bites▇ minor burns ▇sunburn▇ minor skin irritations▇ minor cuts ▇scrapes▇ rashes due to poison ivy, poison oak, and poison sumac ▇dries the oozing and weeping of poison ivy, poison oak ，and poison sumac

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

▇on large areas of the body

▇with any other product containing diphenhydramine, even one taken bymouth

Stop Use

OTC - STOP USE SECTION

▇condition worsens or does not improve within 15 days

▇symptoms persist for more than 15 days or clear up and occur again withina few days

Ask Doctor

OTC - ASK DOCTOR SECTION

▇on chicken pox

▇ on measles

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed, get medical help or contact aPoison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

▇do not use more than directed

▇adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ▇children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

▇protect from excessive heat (40°C/104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water、Ethanol 95%、Ethyl paraben、C18-16 Alcohol、 Mono- and di-glycerol fatty acid esters、 Fatty alcohol polyoxyethylene ether、Liquid paraffin

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84010-102DERMFREE ANTI-ITCH (HYDROCORTISONE ACETATE1%, ANTI-ITCH) CREAM [JIANGXI HEMEI PHARMACEUTICAL CO., LTD]1Unmatched20250423_335652d8-d1d5-47a8-e063-6294a90a53b4.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
84010-10284010-102-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONE ACETATE3X7931PO74ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LAURETH-90AWH8BFG9AIACT
ETHYLPARABEN14255EXE39IACT
PARAFFINUM LIQUIDUMT5L8T28FGPIACT

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
4a4b7831-21c1-74d7-e063-6294a90a1f19335652d8-d1d5-47a8-e063-6294a90a53b42026-02-08WarningsExact identifier
spl set id: 335652d8-d1d5-47a8-e063-6294a90a53b4

Reported adverse events (FAERS/openFDA)#

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