CORTAID MAXIMUM STRENGTH- hydrocortisone cream

Cortaid Maximum Strength by

Drug Labeling and Warnings

Cortaid Maximum Strength 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
• temporarily relieves external anal and genital itching
• other uses of this product should only be under advice and supervision of a doctor

Warnings

For external use only

Do not use

• in the genital area if you have a vaginal discharge.

Consult a doctor

• for the treatment of diaper rash. Ask a doctor.

When using this product

• avoid contact with eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

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
• rectal bleeding occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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: Do not use, ask a doctor
• for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and 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

Other information

• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

water, petrolatum, glycerin, mineral oil, ceteareth-6, dimethicone, VP/eicosene copolymer, phenoxyethanol, stearyl alcohol, ammonium acryloyldimethyltaurate/VP copolymer, cetyl alcohol, carbomer, edetate disodium, methylparaben, sodium citrate, ethylparaben, citric acid, propylparaben, 1sodium hydroxide

1 may contain this ingredient

Questions/comments?

1-800-321-4576

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DOCTOR

RECOMMENDED BRAND

CORTAID®

1% HYDROCORTISONE ANTI-ITCH CREAM

Maximum Strength

Itch Relief

MAXIMUM
STRENGTH

CREAM

Superior results with visibly

healthier skin in 1 day* from:

• Redness
• Dryness
• Flaking

NET WT

1 OZ (28 g)

INGREDIENTS AND APPEARANCE

CORTAID MAXIMUM STRENGTH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-5521
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
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
CETEARETH-6 (UNII: 2RJS3559D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-5521-01	1 in 1 CARTON	10/01/2012
1		28 g in 1 TUBE; 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(0187-5521)