Your browser does not support JavaScript! CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]
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CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (hydrocortisone) lotion
[Chattem, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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)

PRINCIPAL DISPLAY PANEL

CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-0331
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CETYL ALCOHOL 
DIMETHICONE 
DIPROPYLENE GLYCOL 
EDETATE DISODIUM 
GLYCERIN 
GLYCERYL MONOSTEARATE 
MALTODEXTRIN 
METHYLPARABEN 
PETROLATUM 
PHENOXYETHANOL 
POLYSORBATE 60 
PROPYLPARABEN 
VITAMIN A PALMITATE 
SODIUM CITRATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0331-01 in 1 CARTON
199 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/08/2009
Labeler - Chattem, Inc. (003336013)

Revised: 12/2009
 
Chattem, Inc.

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