Cortaid Intensive Therapy Cooling Spray

Cortaid Intensive Therapy Cooling Spray

Drug Labeling and Warnings

Drug Details

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CORTAID INTENSIVE THERAPY COOLING- hydrocortisone spray 
Valeant Pharmaceuticals North America LLC

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.

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Cortaid Intensive Therapy Cooling Spray

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)

Cortaid Intensive Therapy Cooling Spray - 2 fl oz Carton
CORTAID  INTENSIVE THERAPY COOLING
hydrocortisone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0187-5518
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0187-5518-021 in 1 CARTON10/01/2012
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2012
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135MANUFACTURE(0187-5518)

Revised: 12/2018
 
Valeant Pharmaceuticals North America LLC


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