FDA.reportPublic FDA data

ANTI-ITCH FEMININE CARE

Manufacturer
OL PHARMA TECH, LLC Drs PHARMACY | OHIO LAB PHARMA
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:52:20

Label at a glance#

ProductANTI-ITCH FEMININE CARE
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

For temporary external feminine itching

Storage and handling

store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone, USP 0.5%

PURPOSE

OTC - PURPOSE SECTION

Anti-itch

USES

INDICATIONS & USAGE SECTION

For temporary external feminine itching

WARNINGS

WARNINGS SECTION

For External Use Only

Avoid Contact with eyes

DIRETIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older Apply to external vaginal area not more than 3 to 4 times a day
Children under 12 years Consult a doctor

Stop use and ask a doctor if

OTC - DO NOT USE SECTION

  • you have a vaginal discharge. Consult a physician.
  • condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again in a few days.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

feminine carefeminine care

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198707hydrocortisone 0.5 % Topical CreamPSN10
198707hydrocortisone 5 MG/ML Topical CreamSCD10
198707hydrocortisone 0.5 % Topical CreamSY10

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-103-01ANTI-ITCH FEMININE CARE1 in 1 CARTONCREAM110
80489-103-01ANTI-ITCH FEMININE CARE20 g in 1 TUBECREAM2010
80489-103-02ANTI-ITCH FEMININE CARE1 in 1 CARTONCREAM110
80489-103-02ANTI-ITCH FEMININE CARE30 g in 1 TUBECREAM3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-103ANTI-ITCH FEMININE CARE (HYDROCORTISONE 0.5%) CREAM [OL PHARMA TECH, LLC DRS PHARMACY]10Current NDC, Legacy NDC, 4 package rows20250112_d6fa5ff3-ebdc-222d-e053-2a95a90a88d5.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80489-10380489-103-01, 80489-103-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
HYDROCORTISONEWI4X0X7BPJACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
CETEARETH-127V4MR24V5PIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
OCTYLDODECANOL461N1O614YIACT
TROLAMINE9O3K93S3TKIACT

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
ANTI-ITCH FEMININE CAREHYDROCORTISONE 0.5%OL PHARMA TECH, LLC Drs PHARMACYd6fa5ff3-ebdc-222d-e053-2a95a90a88d52025-01-09WarningsExact identifier
ndc (package): 80489-103-02
ndc (package): 80489-103-01
ndc (product): 80489-103
ndc11 (package): 80489010301
ndc11 (package): 80489010302
spl id: 2b51e47c-1642-8a83-e063-6394a90abe5b
spl set id: d6fa5ff3-ebdc-222d-e053-2a95a90a88d5

Reported adverse events (FAERS/openFDA)#

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