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  5. Label Information: Hydrocortisone

FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. STOP USE AND ASK A DOCTOR IF
    8. ASK A DOCTOR BEFORE USE
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. WHEN USING THIS PRODUCT
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENT
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL – 25 UNIT BOX

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



Hydrocortisone 1.0%


Purpose



Antipruritic (Anti itch)


Uses



  • for external genital, feminine and anal itching
  • 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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, scrapes
  • 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 the treatment of diaper rash
  • with any other Hydrocortisone product unless you have consulted a doctor

Ask A Doctor Before Use



  • if you have a vaginal discharge (for feminine itching)
  • for external itching, do not exceed the recommended daily dosage or if condition worsens or if symptoms persist for more than
    7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.



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


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

  • adults for external anal itching when practical, clean, clean the affected area with mild soap and warm water and rinse
    thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • external itching for children under 12 years of age, consult a doctor

When Using This Product



  • avoid contact with eyes
  • do not put this product into rectum by using fingers, mechanical device or applicator

Other Information



  • store at room temperature 15°-30°C (59°-86°F)
  • tamper Evident. Do not use if packet is torn, cut or opened
  • avoid excessive heat and humidity

Inactive Ingredient



emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax


Questions Or Comments?



1-800-869-6970


Principal Display Panel – 25 Unit Box



Maximum Strength

Hydrocortisone
cream 1%

0.9 Gram 25 Single Dose Packets
Distributed by Green Guard®, St. Louis, Missouri 63045


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