Cortizone 10 Cooling Relief
Cortizone-10
bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c
HUMAN OTC DRUG LABEL
Aug 1, 2025
Chattem, Inc.
DUNS: 003336013
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (21)
Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (20)
hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
Fast
Itch
Relief
Last
10
Hours
Calming
Aloe Vera
Itch Relief
*Psoriasis
*Poison Ivy
*Insect Bites
Inflammation & redness
Soothes itch, irritation & rashes
DOCTORS
#1 ITCH MEDICINETM***
RECOMMEND
MAXIMUM STRENGTH
Cortizone-10**®******plus
Net wt 1oz (28g) 1% Hydrocortisone Anti-Itch CREME
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
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eczema
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psoriasis
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poison ivy, oak, sumac
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insect bites
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detergents
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jewelry
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cosmetics
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soaps
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seborrheic dermatitis
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temporarily relieves external anal and genital itching
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other uses of this product should only be under the advice and supervision of a doctor
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SPL UNCLASSIFIED SECTION
Other information
- contents filled by weight, not volume
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient:
Hydrocortisone 1%
OTC - PURPOSE SECTION
Purpose
Anti-itch
WARNINGS SECTION
Warnings
For external use only
Do not use
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in the genital area if you have a vaginal discharge. Consult a doctor.
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for the treatment of diaper rash. Consult a doctor.
When using this product
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avoid contact with eyes
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do not use more than directed unless told to do so by a doctor.
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do not put directly into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
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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
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rectal bleeding occurs
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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
*for external anal and genital itching, adults: * when practical, clean the affected area with mild soap and warm water and rinse thoroughly
* gently dry by patting or blotting with toilet tissue or a soft cloth before applying
* apply to affected area not more than 3 to 4 times daily
* children under 12 years of age: ask a doctor
INACTIVE INGREDIENT SECTION
Inactive Ingredients
aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopheryl acetate, water, zea mays (corn) oil
*Refers to the ingredient hydrocortisone
CHATTEM®
Distributed by CHATTEM, INC.
P.O. Box 2219, Chattanooga,TN 37409-0219 USA ©2008
www.chattem.com 0040435-02