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| Product NDC Code | 0573-0552 | ||||
|---|---|---|---|---|---|
| Drug Name | Preparation h soothing relief anti-itch |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 310868 | ||||
| Application Number | M015 | ||||
| Labeler Name | Haleon US Holdings LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Hydrocortisone 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.PREPARATION H SOOTHING RELIEF ANTI-ITCH hydrocortisone ANHYDROUS CITRIC ACID BUTYLATED HYDROXYANISOLE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CETYL ALCOHOL CITRIC ACID MONOHYDRATE EDETATE DISODIUM GLYCERIN GLYCERYL OLEATE GLYCERYL MONOSTEARATE LANOLIN METHYLPARABEN PROPYL GALLATE PROPYLENE GLYCOL PROPYLPARABEN WATER DIMETHICONE 350 SODIUM BENZOATE SODIUM LAURYL SULFATE STEARYL ALCOHOL PETROLATUM XANTHAN GUM HYDROCORTISONE HYDROCORTISONE off-white viscous cream
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for the treatment of diaper rash. Consult a doctor.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call weekdays from 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug 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
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20–25°C (68–77°F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API