SUNMARK HYDROCORTISONE PLUS

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 of itching 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

OTC - DO NOT USE 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

SPL UNCLASSIFIED SECTION

For External Anal Itching Users

• 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
• children under 12 years of age: consult a doctor

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Before using any medication, read all label direction. Keep this carton. It contains important information.

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, ask a doctor

For External Anal Itching Users

SPL UNCLASSIFIED SECTION

• 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

Other information

STORAGE AND HANDLING SECTION

• unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
• if seal has been broken, do not use this product. Return product to the store where you bought it.
• store at controlled room temperature 59°-86°F
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis, cetearyl alcohol, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

SPL UNCLASSIFIED SECTION

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark _™

hydrocortisone cream 1%

Antipruritic (Anti-Itch)
MAXIMUM STRENGTH PLUS 12 MOISTURIZERS

NET WT 1 OZ (28.4 g)

DailyMed Product Concepts#

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DailyMed Dashboard NDC Coverage#

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DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

• SUNMARK HYDROCORTISONE PLUS
• Hydrocortisone
• CETOSTEARYL ALCOHOL
• CHAMOMILE FLOWER OIL
• CITRIC ACID MONOHYDRATE
• CORN OIL
• GLYCERIN
• GLYCERYL MONOSTEARATE
• ISOPROPYL PALMITATE
• MALTODEXTRIN
• METHYLPARABEN
• MINERAL OIL
• PARAFFIN
• PETROLATUM
• PROPYLENE GLYCOL
• PROPYLPARABEN
• WATER
• SODIUM CETOSTEARYL SULFATE
• SODIUM LAURYL SULFATE
• STEARYL ALCOHOL
• VITAMIN A PALMITATE
• CHOLECALCIFEROL
• .ALPHA.-TOCOPHEROL ACETATE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 572 matching rows.

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.