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

Hydrocortisone

Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Hydrocortisone Cream, USP 1% with Aloe

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT

Hydrocortisone, USP 1%

PURPOSE

Anti-itch

USES

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

  • •eczema
  • •insect bites
  • •poison ivy
  • •poison oak
  • •poison sumac
  • •soaps
  • •jewelry
  • •detergents
  • •cosmetics
  • •psoriasis
  • •seborrheic dermatitis
  • •for external genital, feminine and anal itching
  • •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 external feminine itching if you have a vaginal discharge. Consult a doctor.
  • •for the treatment of diaper rash. Consult a doctor.

WHEN USING THIS PRODUCT

  • •avoid contact with the eyes
  • •do not begin the use of any other hydrocortisone product unless directed by a doctor
  • •for external anal itching:
  • •do not use more than directed unless directed by a doctor
  • •do not put this product into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK A DOCTOR IF

  • •symptoms last for more than 7 days
  • •the condition gets worse
  • •symptoms clear up and occur again in a few days
  • •rectal bleeding occurs, consult doctor promptly

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
  • •do not use, consult a doctor
  •   For external anal itching
  •  Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  •  Children under 12 years of age: consult a doctor

OTHER INFORMATION

  • •Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
  • •Before using any medication, read all label directions.  Keep carton, it contains important information.

INACTIVE INGREDIENT

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

QUESTIONS

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28g tube - 68788-9800-2

Anti-itch Cream

Hydrocortisone CREAM USP 1% WITH ALOE

Compare to the active ingredient in Cortaid® Maximum Strength Cream*

MAXIMUM STRENGTH

Maximum Strength Formula for Temporary Relief of Itching Associated with Irritations, Inflammations and Rashes Due to:

  • •Poison Ivy, Oak, Sumac
  • •Eczema
  • •Insect Bites
  • •Seborrheic Dermatitis
  • •External Genital, Feminine or Anal Itch

NET WT 1 OZ (28 g)

03390311F1 VC110438

Hydrocortisone

Hydrocortisone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-9800(NDC:0472-0339)
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Hydrocortisone HYDROCORTISONE 1 g

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERYL MONOSTEARATE
ISOPROPYL MYRISTATE
METHYLPARABEN
SORBITAN MONOSTEARATE
stearyl alcohol
white wax
POLYOXYL 40 STEARATE
POLYSORBATE 60
propylene glycol
PROPYLPARABEN
water
SODIUM CITRATE
sorbic acid

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9800-2 28 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2012-04-30


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Be sure to consult your doctor before taking any medication!
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