PREPARATION H HYDROCORTISONE

Dosage form: cream
Ingredients: hydrocortisone 10mg in 1g
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-2830

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Preparation H Hydrocortisone
(hydrocortisone)

DRUG FACTS

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

PREPARATION H HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2830
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydrocortisone (hydrocortisone) hydrocortisone10 mg  in 1 g
Product Characteristics
ColorWHITE (off-white viscous cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-2830-101 TUBE (TUBE) in 1 CARTON
126 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/01/2004
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc.829390827MANUFACTURE, ANALYSIS

Revised: 06/2010
 
Pfizer Consumer Healthcare

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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