d6fa5ff3-ebdc-222d-e053-2a95a90a88d5

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
Purpose

Anti-itch

Description

Hydrocortisone, USP 0.5%

Medication Information

Warnings

For External Use Only

Avoid Contact with eyes

Uses

For temporary external feminine itching

Purpose

Anti-itch

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

Hydrocortisone, USP 0.5%

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%

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

Warnings (WARNINGS)

For External Use Only

Avoid Contact with eyes

Uses (USES)

For temporary external feminine itching

Purpose (PURPOSE)

Anti-itch

Other Information (OTHER INFORMATION)
  • store at 20°-25°C (68°-77°F)
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%

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