HYDROCORTISONE- hydrocortisone acetate 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 Acetate 1%            Antipruritic (anti-itch)

Warnings:

For external use only

Purpose

Use:

• For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching.

Do not use:

• in the eyes 
• for diaper rash
• for external genital or feminine itching if you have a vaginal discharge
• more than the recommended daily dosage unless directed by a doctor
• this product in the rectum by using fingers or any mechanical device or applicator

Stop use and ask a physician if:

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product.
•  in case of bleeding when used for anal itching

Keep out of reach of children

Keep out of reach of children.

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

Directions:

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
• When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.

Other information:

• Store at room temperature
• Avoid excessive heat

Inactive ingredients:

Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Liquid Paraffin, Propylene Glycol, Purified water, White Soft Paraffin.

INDICATIONS & USAGE

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching.

Principal Display Panel

1137 Hydro Cort.jpg

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-224-01	28.3 g in 1 TUBE; Type 0: Not a Combination Product	02/02/2010
2	NDC: 67777-224-02	0.9 g in 1 PACKET; Type 0: Not a Combination Product	02/02/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/02/2010

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)