Label: CORTIZONE 10 EASY RELIEF- hydrocortisone liquid
- NDC Code(s): 41167-0032-0
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 13, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient:
- Purpose
-
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
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
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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.
- for the treatment of diaper rash. Consult a doctor.
- Directions
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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
-
INGREDIENTS AND APPEARANCE
CORTIZONE 10 EASY RELIEF
hydrocortisone liquidProduct 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) 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) 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, INC. 003336013 analysis(41167-0032) , manufacture(41167-0032)