HYDROCORTISONE HC- hydrocortisone cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Neopharm Co,. Ltd . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Hydrocortisone 1%

PURPOSE

Purpose
Anti-itch

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  HC
hydrocortisone cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Cetyl alcohol (UNII: 936JST6JCN)
Glycerin (UNII: PDC6A3C0OX)
Squalane (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0002-4	1 in 1 BOX
1		25 g in 1 TUBE

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	Business Operations
Neopharm Co,. Ltd		631101883	manufacture