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  5. Label Information: Hydrocortisone Anti-itch

FDA Label for Hydrocortisone Anti-itch

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - STOP USE
    6. OTC - DO NOT USE
    7. OTHER
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone Anti-itch Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Center Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient

Hydrocortisone 1%


Otc - Purpose



Purpose

Anti-itch


Indications & Usage



Uses

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

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

    • Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor


Warnings



Warnings

  • For external use only
  • Avoid contact with eyes

Otc - Stop Use



Stop using this product and ask a doctor

  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin  to using any other hydrocortisone product

Otc - Do Not Use



Do not use this product and ask a doctor

  • if you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age

Other



For external anal itching users

  • 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 rectum by using fingers or any mechanical device or applicator
  • before using on children under 2 years of age

    • Other information

    • Store at room temperature
    • Lot No. & Exp. Date: see box or see crimp of tube

Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Before using any medication, read all label directions. Keep this carton. It contains important information.


Dosage & Administration



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 users:

    • Adult: when practical, cleanse the affected area with mild soap and 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

Inactive Ingredient



Inactive Ingredients

Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

HYDROCORTISONE ANTI-ITCH CREAM

NET WT 0.5 OZ. (14 g)

image of package label - hydrocortisone anti itch

image of package label - hydrocortisone anti itch


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