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

Purpose

Anti-itch

Description

Drug Facts


Medication 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
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.

Purpose

Anti-itch

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
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

Description

Drug Facts

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.

Active Ingredient

Hydrocortisone 1%

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

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
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.

Purpose

Anti-itch

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
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

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.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

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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