Sunmark ™

Sunmark ™
SPL v4
SPL
SPL Set ID 210079e9-3d2f-4489-b468-b96b145034ed
Route
TOPICAL
Published
Effective Date 2019-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Medium-chain Triglycerides Methylparaben Propylparaben Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1989-10-03 Until 2027-05-31

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

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.

Section 42229-5

Drug Facts

Section 50565-1

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.

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
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
Active Ingredient

Hydrocortisone 1%

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

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
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
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
Principal Display Panel 28.4 G Tube Carton

sunmark

hydrocortisone ointment 1%

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH

NET WT 1 OZ (28.4 g)


Structured Label Content

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Anti-itch

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
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
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (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 (Inactive ingredients)

fractionated coconut oil, methylparaben, propylparaben, white petrolatum

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
Do Not Use This Product and Ask A Doctor (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
Stop Using This Product and Ask A Doctor (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
Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

sunmark

hydrocortisone ointment 1%

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH

NET WT 1 OZ (28.4 g)


Advanced Ingredient Data


Raw Label Data

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