HYDROCORTISONE HC - hydrocortisone cream 
Neopharm Co,. Ltd

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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 :

•   psoriasis
•   seborrheic dermatitis
•   poison ivy,oak,sumac
•   insect bites

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

• apply to affected area not more than 3 to 4 time daily
• for external anal itching: when practical, clean area with mild soap and warm
  

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  HC hydrocortisone   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 51141-0002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (Hydrocortisone) Hydrocortisone 1 g  in 100 g

Inactive Ingredients Ingredient Name Strength Cetyl alcohol   Glycerin   Squalane

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51141-0002-4 1 TUBE In 1 BOX contains a TUBE 1 25 g In 1 TUBE This package is contained within the BOX (51141-0002-4)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/15/2010

Labeler - Neopharm Co,. Ltd (631101883)

Registrant - Neopharm Co,. Ltd (631101883)

Establishment
Name	Address	ID/FEI	Operations
Neopharm Co,. Ltd		631101883	manufacture

Revised: 12/2010Neopharm Co,. Ltd