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Nizoral scalp itch relief - Medication Information

Product NDC Code 55505-222
Drug Name

Nizoral scalp itch relief

Type Brand
Pharm Class Corticosteroid Hormone Receptor Agonists [MoA],
Corticosteroid [EPC]
Active Ingredients
Hydrocortisone 10 mg/ml
Route TOPICAL
Dosage Form SHAMPOO
Application Number M017
Labeler Name Kramer Laboratories
Packages
Package NDC Code Description
55505-222-29 1 bottle in 1 carton (55505-222-29) / 60 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Purpose Hydrocortisone 1.0% Anti-itch liquid
Active ingredientPurpose
Hydrocortisone 1.0%Anti-itch liquid

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 twist the applicator tip to open. if applying after shampooing, towel dry hair before use. squeeze bottle gently to avoid excess dripping. apply solution directly to scalp and massage in. twist applicator tip tightly after use. adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients alcohol denat., aloe barbadensis leaf juice, dipropylene glycol, disodium EDTA, glycerin, hyaluronic acid, menthol, PEG-12 dimethicone, phenoxyethanol and ethylhexylglycerin, polysorbate-80, tocopheryl acetate, water (aqua)

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 temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis seborrheic dermatitis 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.
Active ingredient Purpose Hydrocortisone 1.0% Anti-itch liquid
Active ingredientPurpose
Hydrocortisone 1.0%Anti-itch liquid

Spl product data elements

Usually a list of ingredients in a drug product.
Nizoral Scalp Itch Relief HYDROCORTISONE Hydrocortisone Hydrocortisone Alcohol Aloe Dipropylene Glycol Edetate Disodium Anhydrous Glycerin Hyaluronic Acid Menthol, Unspecified Form Peg-12 Dimethicone (300 Cst) Phenoxyethanol Ethylhexylglycerin Polysorbate 80 .Alpha.-Tocopherol Acetate Water Nizoral Scalp Itch Relief Carton

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 Nizoral ® Scalp Itch Relief HYDROCORTISONE 1% ANTI-ITCH LIQUID RELIEVES SCALP ITCH from seborrheic dermatitis, psoriasis & eczema SOOTHES, CALMS & HYDRATES plus aloe, menthol & hyaluronic acid MAXIMUM STRENGTH anti-itch medicine fragrance-free • greaseless formula 2 fl oz (60mL) NIZORAL ® Scalp Itch Relief contains maximum strength medicine (Hydrocortisone 1%) to relieve scalp itch. The special medicated solution helps soothe, calm, & hydrate an itchy, irritated scalp; plus it contains aloe, menthol, vitamin E & hyaluronic acid. The tapered bottle tip design helps easily apply the medicated solution that's paraben free, fragrance free, and greaseless. Specially formulated with: √ Aloe √ Menthol √ Hyaluronic Acid √ Vitamin E Before use, read all label information. If you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894 KRAMER LABORITORIES Distributed by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA © 2023 KRAMER LABORATORIES, INC.

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product unless you have asked a doctor.

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. If you are allergic to any ingredient in this product

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 the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-824-4894

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 use more than directed unless told to do so by a doctor

Storage and handling

Information about safe storage and handling of the drug product.
Other information store product at 20-25°C (68-77°F) keep carton for full product information.

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. Use only as directed Flammable. Keep away from fire, or flame.

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