DUANE READE - hydrocortisone cream 
Duane Reade

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

Enter section text here

Uses

temporary relief of itching associated with minor skin irritations and rashes due to

other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

Ask a doctor before use if you have

When using this product

consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

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:

Children under 12 years of age: consult a doctor.
For external anal itching:
Children under 12 years of age: consult a doctor.

Other information

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

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DUANE READE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE.284 g  in 28.4 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-034-191 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/21/2011
Labeler - Duane Reade (961956229)
Registrant - Creation's Garden Natural Products (961956229)
Establishment
NameAddressID/FEIBusiness Operations
Creation's Garden Natural Products961956229manufacture

Revised: 3/2011
Document Id: 0702c52c-8594-4a9d-8278-e924fa57e2b2
Set id: bd78a65a-b416-4664-81b2-7b4501cc7470
Version: 1
Effective Time: 20110321
 
Duane Reade