CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA- hydrocortisone lotion

Cortizone 10 Intensive Healing for Eczema by

Drug Labeling and Warnings

Cortizone 10 Intensive Healing for Eczema by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient:

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves the itching and discomfort associated with minor skin irritations, rashes, and inflammation, and due to eczema
  
• other uses of this product should only be 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.

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

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: ask a doctor

Other information

• contents filled by weight, not volume

Inactive Ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serata gum, butyrospermum parkii (shea) butter extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, disodium EDTA, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, retinyl palmitate, sodium citrate, tocopheryl acetate, water, singiber officinale (ginger) root extract (283-035) 

*Clinically proven to moisturize for 24 hours

**Refers to the ingredient hydrocortisone

†Contains 7 healing moisturizers and vitamins A, C & E

Principal Display Panel

NEW!

Fast, Lasting

Itch Relief

MAXIMUM STRENGTH

Cortizone-10®

INTENSIVE HEALING

LOTION†

ECZEMA

And Itchy, Dry Skin

Dermatologist

Recommended

• 7 intensive moisturizers
  
• Clinical strength*

 With

Restora TM 

Botanical &

Vitamin Complex

1% Hydrocortisone Anti-Itch Lotion

DOCTORS

#1 ITCH MEDICINE

RECOMMEND

Net wt 3.5 oz (99g)

INGREDIENTS AND APPEARANCE

CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA 
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0331
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 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0331-0	1 in 1 CARTON	12/08/2009
1		99 g in 1 TUBE; 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	12/08/2009

Labeler - Chattem, Inc. (003336013)