CORTIZONE 10 FAST ACTING ITCH RELIEF COOLING- hydrocortisone spray

Cortizone 10 Fast Acting Itch Relief Cooling by

Drug Labeling and Warnings

Cortizone 10 Fast Acting Itch Relief Cooling by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Hydrocortisone 1%

Purpose

Anti-Itch 

Uses

■ for the temporary relief of 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

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 the eyes 

■ contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. 

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

■ 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, do not use this or 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. Do not use more than 3 to 4 times daily.

■ children under 2 years of age: do not use, ask a doctor.

Other information

Store between 20° to 25°C (68° to 77°F)

Inactive ingredients

alcohol denat., aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, ethoxydiglycol, glycerin, hydroxypropyl cellulose, isobutane, menthyl lactate, methyl gluceth-20, PEG-8, water

Principal Display Panel

Cortizone 10
FAST ACTING
ITCH RELIEF
COOLING SPRAY
SOOTHING ALOE
1% Hydrocortisone
Anti-Itch Spray
Net wt 2.7 oz (76 g)

INGREDIENTS AND APPEARANCE

CORTIZONE 10 FAST ACTING ITCH RELIEF COOLING 
hydrocortisone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0343
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT (UNII: Z6J799EAJK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
ISOBUTANE (UNII: BXR49TP611)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0343-0	76 g in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/03/2025

Labeler - Chattem, Inc. (003336013)