Sunmark Ointment
FDA Label NDC 49348-522

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Sunmark (NDC 49348-522). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, stop using this product and ask a doctor, do not use this product and ask a doctor, for external anal itching users, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by McKesson
One Post Street
San Francisco, CA 94104

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

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

Otc - Keep Out Of Reach Of Children

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

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

Principal Display Panel - 28.4 G Tube Carton

sunmark™

hydrocortisone ointment 1%

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH

NET WT 1 OZ (28.4 g)

Principal Display Panel (28.4 g Tube Carton)

Principal Display Panel (28.4 g Tube Carton)

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