SPL v10
SPL
SPL Set ID d6fa5ff3-ebdc-222d-e053-2a95a90a88d5
Route
TOPICAL
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (5 mg)
Inactive Ingredients
Propylene Glycol Propylparaben .alpha.-tocopherol Methylparaben Edetate Disodium Ceteareth-12 Water Stearic Acid Sodium Cetostearyl Sulfate Cetostearyl Alcohol Octyldodecanol Trolamine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-01
Description

Hydrocortisone, USP 0.5%

Purpose

Anti-itch

Medication Information

Purpose

Anti-itch

Description

Hydrocortisone, USP 0.5%

Uses

For temporary external feminine itching

Warnings

For External Use Only

Avoid Contact with eyes

Diretions

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

Questions

www.drspharmacyusa.com

Package Label

Active Ingredient

Hydrocortisone, USP 0.5%

Other Information
  • store at 20°-25°C (68°-77°F)
Inactive Ingredient

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

Stop Use and Ask A Doctor If
  • 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

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

Structured Label Content

Uses (USES)

For temporary external feminine itching

Purpose (PURPOSE)

Anti-itch

Warnings (WARNINGS)

For External Use Only

Avoid Contact with eyes

Diretions (DIRETIONS)

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

Questions (QUESTIONS)

www.drspharmacyusa.com

Package Label (PACKAGE LABEL)

Active Ingredient (ACTIVE INGREDIENT)

Hydrocortisone, USP 0.5%

Other Information (OTHER INFORMATION)
  • store at 20°-25°C (68°-77°F)
Inactive Ingredient (INACTIVE INGREDIENT)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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 (KEEP OUT OF REACH OF CHILDREN)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.267400 · Updated: 2026-03-14T23:06:57.309434