CORTIZONE 10 EASY RELIEF- hydrocortisone liquid

Cortizone 10 Easy Relief by

Drug Labeling and Warnings

Cortizone 10 Easy Relief by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., CHATTEM, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Warnings

For external use only

Do not use

• in the genital area. Consult a doctor.
  
• for the treatment of diaper rash. Consult a doctor.

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, and do not begin use of any other hydrocortisone product unless you have asked a doctor

Flammable

• keep away from fire or flame

Keep out of reach of children.

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

Directions

• for itching of skin irritation, inflammation, and rashes:
  • 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: ask a doctor

Inactive Ingredients

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, SD alcohol 40-2 (48 %), 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

NEW

MAXIMUM STRENGTH

Cortizone-10®

EASY RELIEF TM 

APPLICATOR

Targets Itch Fast!

• Rashes
  
• Inflammation & Redness
  
• Insect Bites
  
• Eczema & Psoriasis
  
• Fast Acting Liquid
  
• Clean, No Mess

with Healing Aloe

1% HYDROCORTISONE ANTI-ITCH LIQUID

1.25 fl oz (36mL)

INGREDIENTS AND APPEARANCE

CORTIZONE 10 EASY RELIEF 
hydrocortisone liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/01/2008

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	ANALYSIS(41167-0032) , MANUFACTURE(41167-0032)