Hydrocortisone by NeoPharm Co., Ltd. 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

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

• eczema
• psoriasis
• seborrheic dermatitis
• poison ivy, oak, sumac
• insect bites
• soaps and detergents
• cosmetics
• jewelry
• external feminine and anal itching

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 fingers or any mechanical device or applicator
• for external feminine itching if you have a vaginal discharge
• for diaper rash; ask a doctor
  

Ask a doctor or pharmacist before use if you are

using any other hydrocortisone product

When using this product

for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

• condition worsens or does not improve within 7 days
• symptoms clear up and return within a few days
• rectal bleeding occurs
  

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control

Directions

• apply to affected area not more than 3 to 4 times daily
• for external anal itching:  when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
• children under 2 years, or children under 12 years with external anal itching:  do not use, ask a doctor
  

Other information

• store at room temperature, protect from freezing
  

INACTIVE INGREDIENT

Cetyl alcohol, Butylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myristoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water

PRINCIPAL DISPLAY PANEL

Hydrocortisone

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0065
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
Cetyl alcohol (UNII: 936JST6JCN)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0065-1	1 in 1 BOX
1		28 g in 1 TUBE
2	NDC: 51141-0065-5	1 in 1 BOX
2		14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2010

Labeler - NeoPharm Co., Ltd. (631101883)

Registrant - NeoPharm Co., Ltd. (631101883)

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