SUNMARK HYDROCORTISONE- hydrocortisone ointment

sunmark by

Drug Labeling and Warnings

sunmark by is a Otc medication manufactured, distributed, or labeled by McKesson, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

SUNMARK   HYDROCORTISONE
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-522
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Medium-chain triglycerides (UNII: C9H2L21V7U)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-522-72	1 in 1 CARTON	02/13/2013
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/03/1989

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(49348-522)