SPL v3
SPL
SPL Set ID c2876cba-d7e7-de5c-e053-2a95a90a6355
Route
TOPICAL
Published
Effective Date 2022-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Polycarbophil Propylene Glycol Mineral Oil Cetyl Alcohol Water Citric Acid Monohydrate Peg-150 Distearate Ascorbic Acid Vitamin A Palmitate Sodium Citrate Xanthan Gum Stearyl Alcohol Petrolatum Alpha-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-06
Description

Hydrocortisone 1.0%

Medication Information

Indications and Usage

Temporarily relieves external feminine itching

Dosage and Administration
  • Adults and children 12 years and over: Apply to the external vaginal area more than 3 times a day
  • Children under 12 years: Consult a doctor
Description

Hydrocortisone 1.0%

Section 50565-1

If swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask the doctor if :

  • conditions worsen
  • symptoms last ore than 7 days, or clear up and occur again within a few days
Section 50567-7

Avoid contact with the eyes

Section 50570-1

If you are allergic to any of the ingredients

Section 51727-6

aloe vera, Ascorbic acid, Cetyl alcohol, Citric acid, Glyceryl stearate, Mineral oil, PEG-100 Stearate, PEG-150 Distearate, Petrolatum, Phenoxyethanol, Polycarbophil, Propylene Glycol, Purified Water, Sodium citrate, Stearyl alcohol, Vitamin A palmitate, Vitamin E acetate, Xanthan Gum.

Section 51945-4

Section 55105-1

Anti-itch

Section 55106-9

Hydrocortisone 1.0%

Section 60561-8

Store at 20-25 C (68-77 F)

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves external feminine itching

Dosage and Administration (34068-7)
  • Adults and children 12 years and over: Apply to the external vaginal area more than 3 times a day
  • Children under 12 years: Consult a doctor
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask the doctor if :

  • conditions worsen
  • symptoms last ore than 7 days, or clear up and occur again within a few days
Section 50567-7 (50567-7)

Avoid contact with the eyes

Section 50570-1 (50570-1)

If you are allergic to any of the ingredients

Section 51727-6 (51727-6)

aloe vera, Ascorbic acid, Cetyl alcohol, Citric acid, Glyceryl stearate, Mineral oil, PEG-100 Stearate, PEG-150 Distearate, Petrolatum, Phenoxyethanol, Polycarbophil, Propylene Glycol, Purified Water, Sodium citrate, Stearyl alcohol, Vitamin A palmitate, Vitamin E acetate, Xanthan Gum.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-itch

Section 55106-9 (55106-9)

Hydrocortisone 1.0%

Section 60561-8 (60561-8)

Store at 20-25 C (68-77 F)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:51.268401 · Updated: 2026-03-14T23:05:56.026643