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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. DO NOT USE
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. ADULTS AND CHILDREN 2 YEARS AND OVER:
    10. CHILDREN UNDER 2 YEARS:
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL – 0.9G POUCH LABEL
    14. PRINCIPAL DISPLAY PANEL – 25 UNIT BOX LABEL

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 irritation, inflammation and rashes. Other uses of this product should be only under advice and supervision of a doctor


Warnings



For external use only


Do Not Use



  • in the eyes
  • to treat a diaper rash
  • this or any other hydrocortisone product unless you have consulted a doctor

Stop Use And Ask A Doctor If



  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days

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.


Adults And Children 2 Years And Over:



  • apply to affected area not more than 3 to 4 times daily

Children Under 2 Years:



  • do not use, consult a doctor

Other Information



  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients



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


Principal Display Panel – 0.9G Pouch Label



1% HYDROCORTISONE CREAM

ANTI-ITCH CREAM

1/32oz. (0.9g)

Manufactured for Medique Products, Fort Myers, FL 33967 USA


Principal Display Panel – 25 Unit Box Label



MEDI-FIRST
Plus

Hydrocortisone Cream 1%

25 units of 1/32 oz (0.9g) Packets


* Please review the disclaimer below.