Medi-cortisone
FDA Label NDC 49614-404

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medicine Shoppe International Inc for the product Medi-cortisone (NDC 49614-404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - do not use, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
MEDICINE SHOPPE
INTERNATIONAL., INC.
Earth City, MO 63045

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

Uses

  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • external genital and anal itching
    • other uses of this product should be only under the advice and supervision of a doctor

Otc - Do Not Use

For external use only

Do not use

  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask A Doctor Before Use If You Have

  • a vaginal discharge
  • rectal bleeding
  • diaper rash

Otc - When Using

When using this product consult a doctor before exceeding recommended dosage

Stop Use And Ask A Doctor If

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Otc - Keep Out Of Reach Of Children

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, cleanse the affected area with mild soap and warm water and 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

  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol

Principal Display Panel - 28.4 G Tube Carton

NDC 49614-404-10

100%
GUARANTEED ®
SATISFACTION

Maximum Strength
Medi-Cortisone™
Cream 1%
Hydrocortisone Cream 1%
Antipruritic (Anti-Itch)

NET WT 1 oz
(28.4 g)

Principal Display Panel (28.4 g Tube Carton)

Principal Display Panel (28.4 g Tube Carton)

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