Hydrocortisone
Hydrocortisone
f7aecfb4-c194-4554-8d05-4e46005e654b
HUMAN OTC DRUG LABEL
May 27, 2025
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
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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)
INDICATIONS & USAGE SECTION
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
Distributed by:
Taro Pharmaceuticals
** U.S.A., Inc.**
Hawthorne, NY 10532
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Hydrocortisone 1%
OTC - PURPOSE SECTION
Purpose
Anti-itch ointment
WARNINGS SECTION
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
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
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
Inactive ingredients
Fractionated Coconut Oil, Methylparaben, Propylparaben, White Petrolatum
OTC - QUESTIONS SECTION
Questions?
Call 1-866-923-4914