Fixmyskin Healing Balm Vanilla Flavor
Hydrocortisone
Lovely Skin, Inc.
Human Otc Drug
NDC 76314-004Fixmyskin Healing Balm Vanilla Flavor also known as Hydrocortisone is a human otc drug labeled by 'Lovely Skin, Inc.'. National Drug Code (NDC) number for Fixmyskin Healing Balm Vanilla Flavor is 76314-004. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Fixmyskin Healing Balm Vanilla Flavor drug includes Hydrocortisone - 10 mg/mL . The currest status of Fixmyskin Healing Balm Vanilla Flavor drug is Active.
Drug Information:
| Drug NDC: | 76314-004 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Fixmyskin Healing Balm Vanilla Flavor |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydrocortisone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lovely Skin, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROCORTISONE - 10 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 17 Nov, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Lovely Skin, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 203105
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | WI4X0X7BPJ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Corticosteroid Hormone Receptor Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Corticosteroid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 76314-004-01 | 4.43 mL in 1 PACKAGE (76314-004-01) | 17 Nov, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antipruritic, external analgesic
Product Elements:
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
Indications and Usage:
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.
Warnings:
Warnings for external use only. avoid contact with eyes.
Do Not Use:
Warnings for external use only. avoid contact with eyes.
Dosage and Administration:
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.
Stop Use:
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.
Description:
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.
Package Label Principal Display Panel:
Fixmyskin healing balm vanilla flavor 0.15oz/4.43ml (76314-004-01) representative labeling 1 2 3
Further Questions:
Questions or comments? www.fixmyskin.com info@fixmyskin.com (402)697-1100