ANTI-ITCH FEMININE CARE

Manufacturer
OHIO LAB PHARMA
Effective date
2018-11-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:45:35

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

DO NOT USE IF

OTC - DO NOT USE SECTION

you have a vaginal discharge. Consult a physician.

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

anti-itchanti-itch

NET WT 1OZ (20G)

HYDROCORTISONE0.5%

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70648-103-012020-08-25C16284748780-19d75b9d1-00c9-f424-e053-dadaa90a57ce3fb439b4-488d-092a-e054-00144ff8d46c
70648-103-012020-01-31C16284748780-19d75b9d1-00c9-f424-e053-dadaa90a57ce3fb439b4-488d-092a-e054-00144ff8d46c

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
70648-10370648-103-01

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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
ada45551-d191-626f-e053-2a95a90a9f0e3fb439b4-488d-092a-e054-00144ff8d46c2020-08-24WarningsExact identifier
spl set id: 3fb439b4-488d-092a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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