CORTISONE CREAM INTENSIVE HEALING- hydrocortisone cream

Cortisone Cream by

Drug Labeling and Warnings

Cortisone Cream by is a Otc medication manufactured, distributed, or labeled by Tai Guk Pharmaceutical Company, Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Hydrocortisone 1%

PURPOSE

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

Warnings

• for external use only
• avoid contact with eyes
  

DO NOT USE

Do not use

• if you have a vaginal discharge
• for treating diaper rash
• on children under 2 years of age
  

STOP USE

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
• if anal bleeding occurs
  

WHEN USING

When using this product

• for external anal itching do not exceed the recommended daily dosage unless directed by a doctor, do not begin the use of any other hydrocortisone product unless you have consulted a doctor
• do not put this product into rectum by using fingers or any mechanical device or applicator
  

KEEP OUT OF REACH OF CHILDREN

Keep out of 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.

DOSAGE & ADMINISTRATION

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, consult a doctor

For external anal itching

• adults: when practical, cleanse affected area with mild soap and warm water and rinse thoroughly
• 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

STORAGE AND HANDLING

Other Information

• store at 150 to 250 C (590 to 770 F)
  
• Lot No. and Expiration Date see box or crimp of tube.
  

INACTIVE INGREDIENT

Inactive Ingredients

BHA, cetyl alcohol, edetate disodium, glycerin, methylparaben, propylene glycol, propylparaben, purified lanolin, purified water, sodium benzoate, sodium lauryl sulfate, stearic acid, stearyl alcohol, trolamine, white petrolatum, xanthan gum.

QUESTIONS

Questions? Call toll-free 1-800-645-3867

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORTISONE CREAM  INTENSIVE HEALING
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43136-819
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	10 mg  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43136-819-71	1 in 1 CARTON
1		56 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2010

Labeler - Tai Guk Pharmaceutical Company, Limited (631101656)