HYDROCORTISONE- hydrocortisone acetate cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

Anti-itch cream

Uses

• temporary relief of itching associated with minor skin irritations and rashes due to
  • eczema
  • insect bites
  • poison ivy, poison oak, or poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • 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

Do not use

• in the eyes
• by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

• a vaginal discharge
• rectal bleeding
• diaper rash

When using this product consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

• condition gets worse
• condition persists for more than 7 days
• condition clears up and occurs again within a few days.
  Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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

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 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

• store at room temperature
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

Questions?

Call 1-800-925-4733

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Walgreens

NDC: 0363-0972-02

PARABEN FREE

Hydrocortisone 1% Cream

HYDROCORTISONE ACETATE 1% / ANTIPURITIC (ANTI-ITCH)

NET WT 1 OZ (28.4 g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0972
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone Acetate	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0972-02	1 in 1 CARTON	10/26/2018
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	10/26/2018

Labeler - Walgreen Company (008965063)