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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. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product H E B. 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%


Purpose



Anti-itch


Uses



  • •temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • •eczema
  • •psoriasis
  • •poison ivy, oak, sumac
  • •insect bites
  • •detergents
  • •jewelry
  • •cosmetics
  • •soaps
  • •seborrheic dermatitis
  • •temporarily relieves external anal and genital itching
  • •other uses of this product should only be under the advice and supervision of a doctor

Warnings



For external use only


Do Not Use



  • •in the genital area if you have a vaginal discharge. Ask a doctor.
  • •for the treatment of diaper rash. Ask a doctor.

When Using This Product



  • •avoid contact with the eyes
  • •do not use more than directed unless told to do so by a doctor
  • •do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If



  • •condition worsens
  • •symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • •rectal bleeding occurs

Keep Out Of Reach Of Children.



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


Directions



  • •for itching of skin irritation, inflammation, and rashes:
  • •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, ask a doctor
  • •for external anal and genital itching, adults:
  • •when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • •gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • •apply to affected area not more than 3 to 4 times daily
  • •children under 12 years of age: ask a doctor

Other Information



  • •store at 20°-25°C (68°-77°F)

Inactive Ingredients



aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to active ingredient in Cortizone 10®

Maximum Strength

1% Hydrocortisone Cream

ANTI-ITCH CREAM

Plus Soothing Aloe

Maximum Strength

1% Hydrocortisone Cream

ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

Plus Soothing Aloe


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