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| Product NDC Code | 76314-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Fixmyskin healing balm vanilla flavor |
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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 | OINTMENT | ||||
| RxCUI drug identifier | 203105 | ||||
| Application Number | M017 | ||||
| Labeler Name | Lovely Skin, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient & Purpose Active Ingredient Purpose Hydrocortisone 1% ..................................................................Antipruritic, External Analgesic
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Description Formulated by a board-certified dermatologist and his son. Dr. Joel Schlessinger and his son, Daniel Schlessinger, embarked on a five year quest to find the best balm product in a stick formulation for dry skin and irritation. After 54 different formulas, they finally came up with this patent pending formula. It is great for dry skin and helps improve the signs and symptoms of dry skin due to eczema, medications, psoriasis and other dry skin conditions. It is also available in the LovelySkin line without hydrocortisone (www.LovelySkin.com/Balm). Visit www.FixMySkin.com/Story for the whole story on how this product was developed.
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 For itching associated with skin irritation, inflammation and rashes: Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use - consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Ricinus Communis (Castor) Seed Oil, Stearyl Alcohol, C12-15 Alkyl Benzoate, Meadow Foam (Limnanthes Alba) Seed Oil, Shea Butter (Butyrospermum Parkil) Extract, Beeswax, Glycine Soja (Soybean) Germ Extract, Zea Mays (Corn) Starch, Silica, Theobroma Cacao (Cocoa) Seed Butter, Vanilla Flavor.
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 For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, seborrheic dermatitis, insect bites, poison oak, or poison sumac, soaps, detergents, cosmetics, and jewelry, and for external genital and feminine itching, and external analgesic. Other uses of this product should only be under the advice and supervision of a doctor.
Purpose
Information about the drug product’s indications for use.Purpose Antipruritic, External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.FixMySkin Healing Balm Vanilla Flavor HYDROCORTISONE CASTOR OIL STEARYL ALCOHOL ALKYL (C12-15) BENZOATE MEADOWFOAM SEED OIL SHEANUT OIL YELLOW WAX SOYBEAN STARCH, CORN SILICON DIOXIDE COCOA BUTTER VANILLA 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.FixMySkin Healing Balm Vanilla Flavor 0.15oz/4.43ml (76314-004-01) Representative Labeling 1 2 3
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 Keep out of reach of children
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? www.FixMySkin.com [email protected] (402)697-1100
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 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor.
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 eyes.
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