SHOPKO MAXIMUM STRENGTH- hydrocortisone cream

Shopko by

Drug Labeling and Warnings

Shopko by is a Otc medication manufactured, distributed, or labeled by Shopko Stores Operating Co., LLC, 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

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
• temporarily relieves external anal and genital itching
• other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

When using this product

• avoid contact with eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
• rectal bleeding occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for itching of skin irritation, inflammation, and rashes:
  • 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: ask a doctor
• for external anal and genital itching, adults:
  • when practical, clean 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 applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

• To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
• store at room temperature
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

aloe powder, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, paraffin wax, propylparaben, purified water, sodium lauryl sulfate, stearyl alcohol

Questions?

Call 1-866-923-4914

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

NDC: 37012-408-02

SHOPKO®
Maximum Strength

Hydrocortisone Cream 1%

Antipruritic (Anti-Itch)

Itch & Rash Relief with Aloe

NET WT 1 OZ. (28.4 g)

INGREDIENTS AND APPEARANCE

SHOPKO   MAXIMUM STRENGTH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-408
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
cetostearyl alcohol (UNII: 2DMT128M1S)
sodium lauryl sulfate (UNII: 368GB5141J)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
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)
stearyl alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-408-02	1 in 1 CARTON
1		28.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	08/23/1995

Labeler - Shopko Stores Operating Co., LLC (023252638)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(37012-408)