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  5. Label Information: Preparation H Hydrocortisone

FDA Label for Preparation H 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. PRODUCT PACKAGING

Preparation H Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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



  • temporary relief of external anal itching
  • temporary relief of itching associated with minor skin irritations and rashes
  • 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. Consult a doctor.


When Using This Product



  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If



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

Keep Out Of Reach Of Children.



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


Directions



  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
  • when first opening the tube, puncture foil seal with top end of cap
  • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor

Other Information



store at 20-25°C (68-77°F)


Inactive Ingredients



anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl oleate, glyceryl stearate, lanolin, methylparaben, propyl gallate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate, stearyl alcohol, white petrolatum, xanthan gum


Questions Or Comments?



Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374.


Product Packaging



The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

PREPARATION H ANTI-ITCH CREAM HYDROCORTISONE 1%

Relieves the Itch

  • Maximum Strength Without a Prescription
  • Effective Relief of Anal Itch
  • Doctor Prescribed Ingredient

    • NET WT 0.9 OZ (26 g)

    Do Not Use if tube seal under cap embossed with “H” is broken or missing.

    For most recent product information, visit www.preparationh.com.

    Wyeth Consumer Healthcare, Madison, NJ 07940 USA

    ©2009 Wyeth


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