HYDROCORTISONE HC- hydrocortisone cream 
Neopharm Co,. Ltd

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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Hydrocortisone 1%

Active Ingredient
Hydrocortisone 1%


Purpose
Anti-itch

Keep out of reach of children
if swallowed, get medical help or contact a Poison Control

Uses
temporarily relieves itching
associated with minor skin irritation, inflammation and rashes due to :


Other uses of this product: ask a doctor

Warnings
For external use only
Do not use

    * in or near the eyes
    * by putting directly into the rectum by using figers or any mechanical device
      or applicator
    * for diaper rash; ask a doctor

Directions

Inactive ingredients
Cetyl alcohol, Buthylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myreistoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water
Hydrocortosone

hydrocortisone
HYDROCORTISONE  HC
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Cetyl alcohol (UNII: 936JST6JCN)  
Glycerin (UNII: PDC6A3C0OX)  
Squalane (UNII: GW89575KF9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0002-41 in 1 BOX
125 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/15/2010
Labeler - Neopharm Co,. Ltd (631101883)
Registrant - Neopharm Co,. Ltd (631101883)
Establishment
NameAddressID/FEIBusiness Operations
Neopharm Co,. Ltd 631101883manufacture

Revised: 1/2011
Document Id: f06a5c72-ca8a-4147-9a85-ec280e40ef7e
Set id: d01d3dbd-afe6-4e62-853c-84c524b99296
Version: 11
Effective Time: 20110110
 
Neopharm Co,. Ltd