HYDROCORTISONE- hydrocortisone cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                            Purpose

Hydrocortisone USP 10 mg            Antipruritic (anti-itch)

Uses:

For temporary relief of;

• minor skin irritations, inflammation and rashes due to
  

• eczema
• insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• scrapes
  

and for external itching of;

•  genital
• feminine and
• anal itching

• other uses of this product should be only under the advice and supervision of a doctor
  

Warnings:

For external use only

Do not use:

• in the eyes
• longer than 1 week unless directed by a physician
• for diaper rash
• if you have vaginal discharge
• more than the recommended daily dosage unless directed by a doctor
• in the rectum bu using fingers or any other mechanical device or applicator
  

Stop use and ask a physician if:

• the condition persists or gets worse
• symptoms clear up and occur again within a few days
• you are pregnant or breast feeding
  

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.
  

Directions:

Adults and children over 2 years of age

• Apply evenly to affected area no more than 3 or 4 times daily.

Children under 2 years of age

• Do not use
• consult a physician

Adults

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
• apply externally to the area up to 6 times daily or after each bowel movement
  

Other information:

• Store at a controlled room temperature 15 deg - 30 deg C (59 deg - 86 deg F)
• Avoid excessive heat and humidity
• tamper evident, do not use if packet is torn, cut or open
  

Inactive ingredients:

citric acid, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propyl paraben, propylene glycol, purified water, sodium citrate, titanium dioxide,

Indications and Usage

For temporary relief of minor skin irritations and external itching.

PRINCIPAL DISPLAY PANEL

Principal Display

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-237
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-237-01	12 in 1 CASE
1		144 in 1 BOX
1		0.9 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	02/02/2010

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)