Hydrocortisone description, usages, side effects, indications, overdosage, supplying and lots more!

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Hydrocortisone

Qualitest Pharmaceuticals

Hydrocortisone Maximum Strength


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Hydrocortisone 1.0%

Anti-itch

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.

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.

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
  • 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.

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

hydrocortisone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0603-0535
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Hydrocortisone HYDROCORTISONE 10 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.4 in 1 TUBE
2 NDC:0603-0535-50 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2001-10-01


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Be sure to consult your doctor before taking any medication!
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