SUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH- hydrocortisone cream

Sunmark Hydrocortisone with Aloe by

Drug Labeling and Warnings

Sunmark Hydrocortisone with Aloe by is a Otc medication manufactured, distributed, or labeled by McKesson, Taro Phamaceuticals U.S.A., Inc., Taro Phamaceuticals 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

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

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 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 directions. Keep this carton. It contains important information.

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

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

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, cetostearyl alcohol, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol

SPL UNCLASSIFIED SECTION

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

sunmark™

hydrocortisone cream 1%

Antipruritic (Anti-Itch)
MAXIMUM STRENGTH WITH ALOE

NET WT 1 OZ (28.4 g)

INGREDIENTS AND APPEARANCE

SUNMARK HYDROCORTISONE WITH ALOE   MAXIMUM STRENGTH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-521
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
aloe vera leaf (UNII: ZY81Z83H0X)
cetostearyl alcohol (UNII: 2DMT128M1S)
citric acid monohydrate (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)
sodium lauryl sulfate (UNII: 368GB5141J)
stearyl alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-521-72	1 in 1 CARTON	05/01/2014
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49348-521-78	1 in 1 CARTON	05/21/2014
2		60 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	08/23/1995

Labeler - Strategic Sourcing Services LLC (116956644)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Phamaceuticals Inc.		206263295	MANUFACTURE(49348-521)