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Hydrocortisone

Hydrocortisone

Approved
Approval ID

f7aecfb4-c194-4554-8d05-4e46005e654b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydrocortisone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51672-2018
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (5)

MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
HYDROCORTISONEActive
Quantity: 1 g in 100 g
Code: WI4X0X7BPJ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/27/2020

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Itch and Rash Relief
MAXIMUM STRENGTH

Hydrocortisone 1%
** Ointment**

Antipruritic (Anti-Itch)
NET WT 1 oz (28.4 g)

Principal Display Panel - 28.4 g Tube Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/27/2020

Uses

  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • external genital and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 1/27/2020

Distributed by:
Taro Pharmaceuticals
** U.S.A., Inc.**
Hawthorne, NY 10532

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/27/2020

Active ingredient

Hydrocortisone 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/27/2020

Purpose

Anti-itch ointment

WARNINGS SECTION

LOINC: 34071-1Updated: 1/27/2020

Warnings

For external use only

Do not use

  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

  • a vaginal discharge
  • rectal bleeding
  • diaper rash

When using this productconsult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/27/2020

Directions

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: do not use. consult a doctor

For external anal itching:

  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/27/2020

Other information

  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/27/2020

Inactive ingredients

Fractionated Coconut Oil, Methylparaben, Propylparaben, White Petrolatum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/27/2020

Questions?

Call 1-866-923-4914

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Hydrocortisone - FDA Drug Approval Details