DUANE READE- hydrocortisone cream

Duane Reade by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient..........................Purpose

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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
• conditions 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 12 years of age: 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

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 INGREDIENT

purified water/aqua/eau; glyceryl stearate and peg-100 stearate; c12-15 alkyl benzoate; isopropyl myristate; cetearyl alcohol and ceteareth-20; magnesium aluminum silicate; aloe barbadensis leaf juice; citric acid; polysorbate 80; sodium lauryl sulfate; propylene glycol,diazolidinyl urea, methlyparaben, propylparaben

Questions?

Call 1-866-923-4914

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

DUANE READE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-034
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
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-034-19	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	03/21/2011

Labeler - Duane Reade (961956229)

Registrant - Creation's Garden Natural Products (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creation's Garden Natural Products		961956229	manufacture