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Drug Facts
Preparation H Soothing Relief Anti-itch Cream
FDA Label NDC 0573-0552
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Preparation H Soothing Relief Anti-itch (NDC 0573-0552). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Hydrocortisone 1%
Otc - Purpose
Purpose
Anti-itch
Indications & Usage
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
Warnings
For external use only
Otc - Do Not Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
Storage And Handling
Other information
store at 20–25°C (68–77°F)
Inactive Ingredient
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
Otc - Questions
Questions or comments?
Call weekdays from 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374
Principal Display Panel - 26 G Tube Label
PREPARATION H®
soothing
RELIEF
anti-itch cream
HYDROCORTISONE 1%
Maximum Strength
Without a Prescription
Effective Itch Relief
No Added Fragrance
NET WT 0.9 OZ (26 g)
Principal Display Panel (26 g Tube Label)
Principal Display Panel - 26 G Tube Carton
NEW!
PREPARATION H®
soothing
RELIEF
anti-itch cream
HYDROCORTISONE 1%
Maximum Strength
Without a Prescription
Effective Itch Relief
No Added Fragrance
ONE TUBE / NET WT 0.9 0Z (26 g)
Principal Display Panel (26 g Tube Carton)
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