Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflamation and rashes due to:

soaps
jewelry
insect bites
psoriasis
eczema
detergents
seborrheic dermatitis
external genital and anal itching
poison ivy, poison oak, or poison sumac

Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Do not use

for the treatment of diaper rash. Consult a doctor.
for external genital itching if you have vaginal discharge. Consult a doctor.

When using this product

avoid contact with eyes
do not begin the use of any other hydrocortisone product unless you have consulted a doctor
for external anal itching, do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

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

do not use. Consult a doctor.

For external anal itching

adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product
children under 12 years of age with external anal itching: consult a doctor

Other information

store at 15° to 30°C (59° to 86°F)
lot number and expiration date: See crimp of tube or box

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

cetyl alcohol, diazolidinyl urea, isopropyl palmitate, mineral oil/lanolin alcohol, polysorbate 40, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol, xanthan gum

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 6/10 R4
8265556 0534

PRINCIPAL DISPLAY PANEL

This is an image of the carton for Maximum Strength Hydrocortisone 1% Cream.

HYDROCORTISONE
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0603-0535
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (HYDROCORTISONE)	HYDROCORTISONE	10 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL
DIAZOLIDINYL UREA
ISOPROPYL PALMITATE
MINERAL OIL
LANOLIN ALCOHOLS
POLYSORBATE 40
PROPYLENE GLYCOL
PROPYLENE GLYCOL MONOSTEARATE
WATER
SORBIC ACID
SORBITAN MONOPALMITATE
STEARYL ALCOHOL
XANTHAN GUM

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0603-0535-50	1 TUBE In 1 CARTON	contains a TUBE
1		28.4 g In 1 TUBE	This package is contained within the CARTON (0603-0535-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/01/2001

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		825839835	MANUFACTURE

Revised: 08/2010Qualitest Pharmaceuticals