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  5. Label Information: Hydrocortisone

FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. OTHER
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma Inc. 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.

Active Ingredient



Hydrocortisone 1% (Micronized)


Purpose



Antipruritic (Anti-itch)


Use



For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:

  • insect bites
  • eczema
  • psoriasis
  • soaps
  • detergents
  • cosmetics,
  • jewelry,
  • poison oak,
  • poison sumac
  • Other uses of this product should be undertaken only under the advice and supervision of a doctor.

Warnings



For external use only.


When Using This Product



Do not get into eyes. If contact occurs, rinse thoroughly with water.


Stop Use And Ask A Doctor If



  • Condition worsens
  • If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • Do no use for diaper rash. Consult a doctor.

Keep Out Of Reach Of Children



Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.


Directions



  • Shake will before using.
  • For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
  • For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.

Other Information



• Store away from excessive heat or cold. Shake well before using.


Inactive Ingredients



Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, Xanthan Gum


Questions?



Please Call 1(877) 225-6999


Other



Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

Rev. 03/19

Manufactured in U.S.A


Package Label.Principal Display Panel



carton - hydroc lotion

carton - hydroc lotion


* Please review the disclaimer below.