CORTAID INTENSIVE THERAPY COOLING- hydrocortisone spray

Cortaid by

Drug Labeling and Warnings

Cortaid by is a Otc medication manufactured, distributed, or labeled by Bausch Health US, LLC, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema
• insect bites
• poison ivy, oak, or sumac
• soaps
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• other uses of this product should only be 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.
• for external anal, genital or vaginal itching
• in or near eyes

When using this product

avoid contact with eyes. If contact with eyes occurs, flush liberally with water.

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: Do not use, ask a doctor

Other information

• store at 20° to 25°C (68° to 77°F)
• protect from freezing

Inactive ingredients

citric acid, disodium EDTA, glycerin, poloxamer 188, polysorbate 20, SD alcohol 40-B, water

Questions/comments?

1-800-321-4576

Distributed by:

Valeant Pharmaceuticals North America LLC,

Bridgewater, NJ 08807 USA

Cortaid is a registered trademark of Valeant Pharmaceuticals International, Inc. or its affiliates

©2015 Valeant Pharmaceuticals North America LLC

9421501

Principal Display Panel

DOCTOR RECOMMENDED BRAND

CORTAID®

1% HYDROCORTISONE ANTI-ITCH SPRAY

ITCH

DISRUPTING

FORMULA™

for instant

cooling relief

INTENSIVE

THERAPY

COOLING SPRAY

Relieves your worst

itch due to:

• Eczema
• Psoriasis
• Seborrheic Dermatitis
• Rashes

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

CORTAID  INTENSIVE THERAPY COOLING
hydrocortisone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-5518
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 188 (UNII: LQA7B6G8JG)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-5518-02	1 in 1 CARTON	10/01/2012
1		59 mL in 1 BOTTLE; 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	10/01/2012

Labeler - Bausch Health US, LLC (831922488)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	MANUFACTURE(0187-5518)