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  5. Label Information: Hydrocortisone

FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH GRAM)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENT
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL – 144 UNIT BOX LABEL
    12. PRINCIPAL DISPLAY PANEL – POUCH

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. 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.

Other



Drug Facts


Active Ingredient (In Each Gram)



Hydrocortisone 1.0%


Purpose



Anti-itch


Uses



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

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • cosmetics
  • jewelry
  • soaps
  • detergents
  • seborrheic dermatitis
  • psoriasis

    • Other uses of this product should be only under the advice and supervision of a doctor


Warnings



For external use only

  • avoid contact with the eyes
  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • do not use for the treatment of diaper rash

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • for 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

Other Information



  • store at room temperature 59°-86°F (15°-30°C)
  • do not freeze
  • do not use any opened or torn packets

Inactive Ingredient



Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax


Questions Or Comments?



1-800-634-7680


Principal Display Panel – 144 Unit Box Label



MEDI-FIRST

1% Hydrocortisone
Cream

Temporary relief of itching associated with
minor skin irritation, inflammation and rashes

Para el alivio temporal de la comezón asociada con leves
irritaciones, inflamaciones y sarpullidos de la piel

0.9g (1/32oz) Packets
144 per box


Principal Display Panel – Pouch



1% HYDROCORTISONE CREAM

ANTI-ITCH CREAM

1/32oz. (0.9g)

Manufactured for Medique Products, Fort Myers, FL 33967 USA


* Please review the disclaimer below.