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sunmark

McKesson
Taro Pharmaceuticals U.S.A., Inc.

sunmark Hydrocortisone


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

sunmark Uses

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

  • for external use only
  • avoid contact with the eyes
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop using this product and ask a doctor

  • in case of bleeding
  • 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

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

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 out of the reach of children.

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

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

Directions

  • 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
  • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: Do not use, consult a doctor

sunmark Other information

  • to open: unscrew cap and pull tab to remove foil seal
  • if seal has been broken, do not use this product. Return product to the store where you bought it
  • store at controlled room temperature 15° – 30°C ( 59°- 86°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

fractionated coconut oil, methylparaben, propylparaben, white petrolatum

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

sunmark

hydrocortisone ointment 1%

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH

NET WT 1 OZ (28.4 g)

sunmark

sunmark

Hydrocortisone OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-522
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Hydrocortisone HYDROCORTISONE 1 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
METHYLPARABEN
PROPYLPARABEN
petrolatum

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.4 in 1 TUBE
2 NDC:49348-522-72 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 1989-10-03


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Be sure to consult your doctor before taking any medication!
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