FDA.reportPublic FDA data

999 ITCH RELIEVING OINTMENT

Manufacturer
Guangdong CR. Shunfeng Pharmaceutical Co Ltd
Effective date
2016-11-14
Label type
HUMAN OTC DRUG LABEL
Version
32287
Source
full-release
Hydrated at
2026-05-31 22:48:00

Label at a glance#

Product999 ITCH RELIEVING
Active ingredientHYDROCORTISONE
Label structure11 sections

Dosage and administration

Adult and children 2 years of age and older. Apply liberally to affected area not more than 5 times daily and 5-8 times per day for some severe cases or follow doctor's instruction.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Use

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: cosmetics, insect bites, psoriasis, eczema, seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and seek medical advice if

OTC - STOP USE SECTION

Condition worsens. Symptoms persist for more than 7 days. Symptoms clear up and occur again within a few days. Excessive irritation of the skin develops.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 2 years of age and older. Apply liberally to affected area not more than 5 times daily and 5-8 times per day for some severe cases or follow doctor's instruction.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnant and children under 2 years of age. Do not use, consult a doctor.

Other Information

OTHER SAFETY INFORMATION

Keep in a tightly closed container. Store at 8 to 30 ℃ (46-86℉) in a dry place away from sunlight.

You may report serious side effects to: 1452 W. Holt Ave, Pomona, CA 91768

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glyceryl Monostearate, Glyceryl Distearate, Glycerin, Stearic Acid, White Petrolatum, Ethylparaben, Sodium Lauryl Sulfate, Water

SPL UNCLASSIFIED SECTION

Manufactured By Guangdong CR. Shunfeng Pharmaceutical Co.; Ltd.

Jinjuzu, Dalinag Street, Shunde District, Foshan, Guangdong, China 528300

Distributed by Master Herbs Inc.

1452 W. Holt Ave, Pomona, CA 91768

(866)487-8373

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
203105hydrocortisone 1 % Topical OintmentPSN32287
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD32287
203105hydrocortisone 1 % Topical OintmentSY32287

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69436-931-202020-01-31C16284748780-19d75b9d0-6217-f424-e053-dadaa90a57ce999 ITCH RELIEVING OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69436-931-20999 ITCH RELIEVING20 g in 1 TUBEOINTMENT2032287
69436-931-20999 ITCH RELIEVING1 in 1 BOXOINTMENT132287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69436-931999 ITCH RELIEVING (HYDROCORTISONE) OINTMENT [GUANGDONG CR. SHUNFENG PHARMACEUTICAL CO LTD]32287Legacy NDC, 2 package rows20161115_fecdc698-c9f4-483f-ad4d-3c19eff085bd.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69436-93169436-931-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERYL DISTEARATE73071MW2KMIACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
PETROLATUM4T6H12BN9UIACT
ETHYLPARABEN14255EXE39IACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT

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
b80253d2-a37c-4771-816e-6ad4dfc62430fecdc698-c9f4-483f-ad4d-3c19eff085bd2016-11-14WarningsExact identifier
spl id: b80253d2-a37c-4771-816e-6ad4dfc62430
spl set id: fecdc698-c9f4-483f-ad4d-3c19eff085bd

Reported adverse events (FAERS/openFDA)#

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