DUANE READE HYDROCORTISONE- 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 Ingredients..........................Purpose

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

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

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:

Children under 2 years of age: do not use, consult a doctor

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

Other information

Inactive Ingredients

Petrolatum

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DR_hydrocortisone_ointment_Max_Strength_ Label

DUANE READE  HYDROCORTISONE
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-033
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
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-033-181 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/18/2011
Labeler - Duane Reade (961956229)
Registrant - Creations Garden Natural Products (961956229)
Establishment
NameAddressID/FEIBusiness Operations
Creations Garden Natural Products961956229manufacture

Revised: 3/2011
Document Id: c8c131c2-1345-47a0-9ea3-cf08ae04dc1b
Set id: e442afb3-cecf-45d4-90b3-b6eafe12b7ee
Version: 1
Effective Time: 20110318
 
Duane Reade