Drug Facts
d6148d77-ef6f-4552-b5ba-43b429923f19
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient Hydrocortisone 1%
Medication Information
Warnings and Precautions
Warnings
For external use only
Indications and 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
Dosage and 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
Description
Active ingredient Hydrocortisone 1%
Section 44425-7
Other information
store at 20–25°C (68–77°F)
Section 50565-1
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Section 50570-1
Do not usefor the treatment of diaper rash. Consult a doctor.
Section 51727-6
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
Section 53413-1
Questions or comments?
Call weekdays from 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374
Section 55105-1
Purpose
Anti-itch
Section 55106-9
Active ingredient
Hydrocortisone 1%
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.
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 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)
Structured Label Content
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
Warnings
For external use only
Section 44425-7 (44425-7)
Other information
store at 20–25°C (68–77°F)
Section 50565-1 (50565-1)
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Section 50570-1 (50570-1)
Do not usefor the treatment of diaper rash. Consult a doctor.
Section 51727-6 (51727-6)
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
Section 53413-1 (53413-1)
Questions or comments?
Call weekdays from 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374
Section 55105-1 (55105-1)
Purpose
Anti-itch
Section 55106-9 (55106-9)
Active ingredient
Hydrocortisone 1%
When Using This Product (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 (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.
Principal Display Panel 26 G Tube Label (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 Carton (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)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:28.329764 · Updated: 2026-03-14T23:09:15.187219