HYDROCORTISONE MAXIMUM STRENGTH - hydrocortisone cream
H E B

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewelry
seborrheic dermatitis
soaps
external genital 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

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

When using this product

avoid contact with the eyes
do not begin use of any other hydrocortisone product unless you have asked 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 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:

do not use. Ask a doctor.

for external anal itching:

adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry 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: ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Cortaid®

Maximum Strength

1% Hydrocortisone Cream with Aloe

Anti-Itch Cream

1% Hydrocortisone Cream with Aloe Carton Image 1

1% Hydrocortisone Cream with Aloe Carton Image 2

HYDROCORTISONE MAXIMUM STRENGTH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-541
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (HYDROCORTISONE)	HYDROCORTISONE	1 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
CETYL PALMITATE
GLYCERIN
ISOPROPYL MYRISTATE
METHYLPARABEN
WATER

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37808-541-64	1 TUBE ( TUBE) in 1 CARTON	contains a TUBE
1		28 g in 1 TUBE	This package is contained within the CARTON (37808-541-64)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/23/2010

Labeler - H E B (007924756)

Revised: 08/2010 H E B