Active ingredient (in each gram)

Hydrocortisone USP 10mg

Purpose

Antipuritic (Anti Itch)

Uses

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, scrapes
for external 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

Do not use

for the treatment of diaper rash
with any other Hydrocortisone product unless you have consulted a doctor

Consult a doctor

before use if you have a vaginal discharge (for external feminine itching)
for external itching, do not exceed the recommended daily dosage or if bleeding occurs
if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When using this product

avoid contact with eyes
do not put this product into rectum by using fingers or any mechanical device or applicator

Keep out of reach of children.

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

Directions

For 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
Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Children under 12 years of age: for external anal itching, consult a doctor.

Other information

Protect from freezing. Avoid excessive heat.
Do not use if packet is torn, cut or opened.

Inactive ingredients

Citric acid, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide

Package/Label Principal Display Panel

Curad Hydrocortisone Cream

CURAD

WE HELP HEAL

HYDROCORTISONE CREAM 1%

anti itch

Latex free

NET WT. 1 oz (28.4 g)

ANTI-ITCH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	53329-091
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
CITRIC ACID MONOHYDRATE
GLYCERIN
GLYCERYL STEARATE CITRATE
METHYLPARABEN
PETROLATUM
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE
TITANIUM DIOXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	53329-091-01	1 TUBE In 1 BOX	contains a TUBE
1		28.4 g In 1 TUBE	This package is contained within the BOX (53329-091-01)
2	53329-091-91	48 PACKET In 1 CARTON	contains a PACKET (53329-091-90)
2	53329-091-90	1.5 g In 1 PACKET	This package is contained within the CARTON (53329-091-91)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	03/01/2010

Labeler - Medline Industries, Inc. (025460908)

Revised: 07/2010Medline Industries, Inc.