Sunmark ™

Sunmark ™
SPL v4
SPL
SPL Set ID ed6b197d-972a-455d-86be-bf2e8ec12b16
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
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1989-10-03 Until 2026-05-31

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 50570-1
  • for external use only
  • avoid contact with the eyes
Directions
  • 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
Active Ingredient

Hydrocortisone 1%

Other Information
  • 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

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).

For External Anal Itching Users
  • 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
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
  • 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 cream 1%

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH PLUS 12 MOISTURIZERS

NET WT 1 OZ (28.4 g)

Keep This and All Drugs 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 direction. Keep this carton. It contains important information.


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 50570-1 (50570-1)
  • for external use only
  • avoid contact with the eyes
Purpose

Anti-itch

Directions
  • 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
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • 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 ingredients)

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).

For External Anal Itching Users
  • 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
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)
  • 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 cream 1%

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH PLUS 12 MOISTURIZERS

NET WT 1 OZ (28.4 g)

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs 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 direction. Keep this carton. It contains important information.


Advanced Ingredient Data


Raw Label Data

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