HYDROCORTISONE- hydrocortisone cream 
Preferred Pharmaceuticals, Inc

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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Hydrocortisone

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflamation and rashes due to:

  • soaps
  • jewelry
  • insect bites
  • psoriasis
  • eczema
  • detergents
  • seborrheic dermatitis
  • external genital and anal itching
  • poison ivy, poison oak, or poison sumac

Other uses of this product should be only 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.
  • for external genital itching if you have vaginal discharge. Consult a doctor.

When using this product

  • avoid contact with eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor
  • for external anal itching, do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
  • do not put this product 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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

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. Consult a doctor.

For external anal itching

  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age with external anal itching: consult a doctor

Other information

  • store at 15° to 30°C (59° to 86°F)
  • lot number and expiration date: See crimp of tube or box

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

cetyl alcohol, diazolidinyl urea, isopropyl palmitate, mineral oil/lanolin alcohol, polysorbate 40, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol, xanthan gum

How Supplied

28 gram tube - 68788-9856-2

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 6/10 R4
8265556  0534

Relabeled By Preferred Pharmaceuticals, Inc

PRINCIPAL DISPLAY PANEL

Hydrocortisone 1% cream label
HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68788-9856(NDC:0603-0535)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
DIAZOLIDINYL UREA 
ISOPROPYL PALMITATE 
MINERAL OIL 
LANOLIN ALCOHOLS 
POLYSORBATE 40 
PROPYLENE GLYCOL 
PROPYLENE GLYCOL MONOPALMITOSTEARATE 
WATER 
SORBIC ACID 
SORBITAN MONOPALMITATE 
STEARYL ALCOHOL 
XANTHAN GUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9856-228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/12/2012
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9856)

Revised: 3/2012
 
Preferred Pharmaceuticals, Inc