Cortizone-10® Easy Relief Applicator

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

Warnings

For external use only

Flammable. Keep away from fire or flame.

Do not use

for the treatment of diaper rash. Consult a doctor.
if you are allergic to any ingredient in this product

When using this product

avoid contact with eyes
do not use more than directed unless told to do so by a doctor.

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, do not use this or any other hydrocortisone product unless you have asked a doctor

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 by placing applicator on skin, press firmly and hold to activate the dispensing of liquid. Do not use more than 3 to 4 times daily.
children under 2 years of age: do not use, ask a doctor

Inactive Ingredients

Alcohol denat. (45%), aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, hydroxyethyl cellulose, maltodextrin, menthyl lactate, methyl gluceth-20, PEG-8, , sodium citrate, water

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION.

Close cap tightly after use. 0042734-03

*Refers to the ingredient hydrocortisone

CHATTEM®

Distributed by: Chattem, Inc.
P.O. Box 2219, Chattanooga,TN 37409-0219
U.S.A. ©2008 www.chattem.com

Principal Display Panel

MAXIMUM STRENGTH

Cortizone●10®

EASY RELIEFTM

APPLICATOR

Targets Itch Fast!

Insect Bites
Redness & Inflammation
Skin Irritation & Rashes
No Mess

with Healing Aloe

1% HYDROCORTISONE ANTI-ITCH LIQUID

1.25 fl oz (36mL) Principal Display Panel
MAXIMUM STRENGTH
Cortizone●10®
EASY RELIEFTM
APPLICATOR
Targets Itch Fast!
• Insect Bites
• Redness & Inflammation
• Skin Irritation & Rashes
• No Mess
with Healing Aloe
1% HYDROCORTISONE ANTI-ITCH LIQUID
1.25 fl oz (36mL)

CORTIZONE 10 EASY RELIEF
hydrocortisone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0032
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT (UNII: Z6J799EAJK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
ALCOHOL (UNII: 3K9958V90M)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41167-0032-0	1 in 1 CARTON	10/01/2008
1		37 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/01/2008

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
CHATTEM, INC.		003336013	analysis(41167-0032) , manufacture(41167-0032)

Cortizone 10 Easy Relief