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Hydrocortisone by Qualitest Pharmaceuticals

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0535

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.

Hydrocortisone Maximum Strength

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

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

  • cosmetics
  • 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 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 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

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 8/11 R5
8265556  0534

PRINCIPAL DISPLAY PANEL

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 STEARATE 
WATER 
SORBIC ACID 
SORBITAN MONOPALMITATE 
STEARYL ALCOHOL 
XANTHAN GUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0535-501 TUBE (1 TUBE) in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/01/2001
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0535)

Revised: 07/2012
 
Qualitest Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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