CORTAID 12-HOUR ADVANCED ANTI-ITCH CREAM

CORTAID 12-HOUR ADVANCED ANTI-ITCH CREAM

Drug Labeling and Warnings

Drug Details

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CORTAID 12-HOUR ADVANCED ANTI-ITCH- hydrocortisone cream 
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 12-HOUR ADVANCED ANTI-ITCH CREAM

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

Do not use

for the treatment of diaper rash. Consult a doctor.

When using this product

avoid contact with eyes

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: ask a doctor

Other information

  • store at 20° to 25°C (68 to 77°F)

Inactive ingredients

aloe barbadensis leaf juice, benzyl alcohol, ceteareth-20, cetearyl alcohol, cetyl palmitate, citric acid, cyclopentasiloxane, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, feverfew extract, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, oat kernel extract, PEG-40 stearate, potassium lactate, *sodium hydroxide, water *may contain this ingredient

Questions/comments:

1-800-321-4576

Package/Label Principal Display Panel

DOCTOR

RECOMMENDED BRAND

CORTAID®

HYDROCORTISONE ANTI-ITCH CREAM

Lasts

longer than

Cortizone-10®*

12-HOUR

ADVANCED

ANTI-ITCH CREAM

With

ITCH-SHIELD technology.

Seals maximum strength

medicine for 12 hours

NET WT

1.5OZ (42 g)

Cortaid 12 Hour Advanced Anti-Itch Cream - 1.5 oz Carton
CORTAID 12-HOUR ADVANCED  ANTI-ITCH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0187-5519
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DEANOL (UNII: 2N6K9DRA24)  
TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
OAT (UNII: Z6J799EAJK)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0187-5519-151 in 1 CARTON10/01/2012
142 g in 1 TUBE; 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(0187-5519)

Revised: 12/2016
 
Valeant Pharmaceuticals North America LLC


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