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Product NDC Code | 63824-851 | ||||
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Drug Name | Scalpicin anti-itch maximum strength |
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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 | LIQUID | ||||
RxCUI drug identifier | 310869, 1039273 |
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Application Number | part348 | ||||
Labeler Name | RB Health (US) LLC | ||||
Packages |
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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 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; consult a doctor twist the flow-control cap to open apply at first signs of itching if using after shampooing, towel dry hair apply from bottle directly to scalp, massage in to avoid running or dripping, do not squeeze bottle too hard
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, Melaleuca Alternifolia Leaf Oil, Menthol, PEG-40/PPG-8 Methylaminopropyl/Hydroxypropyl Dimethicone Copolymer, Propylene Glycol, t-Butyl Alcohol, Tocopheryl Acetate, Water
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 and rashes due to seborrheic dermatitis eczema psoriasis 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 liquid
Spl product data elements
Usually a list of ingredients in a drug product.Scalpicin Anti-Itch Maximum Strength Hydrocortisone WATER PROPYLENE GLYCOL GLYCERIN DIPROPYLENE GLYCOL MENTHOL, UNSPECIFIED FORM EDETATE DISODIUM ALOE VERA LEAF ISOPROPYL ALCOHOL TEA TREE OIL .ALPHA.-TOCOPHEROL ACETATE HYDROCORTISONE HYDROCORTISONE
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 - 44 mL Bottle Carton SCALPICIN ® MAXIMUM STRENGTH Hydrocortisone 1% Anti-Itch Liquid SCALP ITCH RELIEF on the GO WITH ALOE 1.5 FL OZ (44 mL) Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed by: RB Health (US) Parsippany, NJ 07054-0224
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? 1-866-252-5327 You may also report side effects to this phone number.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20-25 °C (68-77°F) protect from humidity flammable. Keep away from fire, flame or heat. 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 Avoid contact with the eyes If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor Do not use for the treatment of diaper rash. Consult 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