DUANE READE HYDROCORTISONE- hydrocortisone cream

Duane Reade by

Drug Labeling and Warnings

Duane Reade by is a Otc medication manufactured, distributed, or labeled by Duane Reade, Creations Garden Natural Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients..........................Purpose

Hydrocortisone 1%..........................Anti-Itch

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 or 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 other 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 contract 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

• 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

Petrolatum

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

DUANE READE  HYDROCORTISONE
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	.284 g  in 28.4 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-033-18	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	03/18/2011

Labeler - Duane Reade (961956229)

Registrant - Creations Garden Natural Products (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products		961956229	manufacture