Hydrocortisone

Label at a glance#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

For the temporary relief associated with minor skin irritations, inflammation and rashes due to:

• eczema
• seborrheic dermatitis
• psoriasis
• insect bites
• poison ivy, oak, sumac
• soaps
• detergents
• cosmetics
• jewelry
• external genital and anal itching.

Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

• For external use only
• avoid contact with the eyes

Stop using this product and ask a doctor

OTC - STOP USE SECTION

• if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

OTC - DO NOT USE SECTION

• if you have a vaginal discharge
• before treating diaper rash
• before using on children under 2 years of age

For external anal itching users

SPL UNCLASSIFIED SECTION

• do not exceed the recommended daily dosage unless directed by a doctor
• in case of bleeding, consult a doctor promptly
• do not put this product into the rectum by using fingers or any mechanical device or applicator

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

For External Anal Itching Users

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, and 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

Other Information

STORAGE AND HANDLING SECTION

• store at 55 to 76F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

stearic acid, propylene glycol, lanolin alcohol in mineral oil, isopropyl in myristate, cetyl alcohol, mono- and di-glycerides, polysorbate 80, sorbitan monooleate, a scent and purified water preserved with methylparaben and propylparaben.

PRINCIPAL DISPLAY PANEL - 114 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0394-0859-32

Mericon Industries, Inc.

Hydrocortisone 1%
Lotion

Anti-Itch
Poison Ivy
Poison Oak
Poison Sumac
Hives • Rashes

Net Wt. 4 oz. (114g)

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• Hydrocortisone
• STEARIC ACID
• PROPYLENE GLYCOL
• LANOLIN ALCOHOLS
• MINERAL OIL
• MYRISTIC ACID
• CETYL ALCOHOL
• POLYSORBATE 80
• SORBITAN MONOOLEATE
• WATER
• METHYLPARABEN
• PROPYLPARABEN

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.