Licefreee Ultimate Family Kit
Head Lice Treatment
Tec Laboratories, Inc.
Human Otc Drug
NDC 51879-300Licefreee Ultimate Family Kit also known as Head Lice Treatment is a human otc drug labeled by 'Tec Laboratories, Inc.'. National Drug Code (NDC) number for Licefreee Ultimate Family Kit is 51879-300. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Licefreee Ultimate Family Kit drug includes . The currest status of Licefreee Ultimate Family Kit drug is Active.
Drug Information:
| Drug NDC: | 51879-300 |
| 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: | Licefreee Ultimate Family Kit |
| 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: | Head Lice Treatment |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Tec Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| 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: | UNAPPROVED HOMEOPATHIC |
| 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: | 09 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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. |
| 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: | Tec Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51879-300-12 | 1 KIT in 1 KIT (51879-300-12) * 354.9 mL in 1 BOTTLE, PLASTIC | 09 Feb, 2022 | 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:
Peduculosis remedy
Product Elements:
Licefreee ultimate family kit head lice treatment licefreee head lice treatment water benzyl alcohol poloxamer 188 sodium chloride sodium cation
Indications and Usage:
Uses for the treatment of headlice public (crab) lice body lice
Warnings:
Warnings for external use only
When Using:
When using this product do not use in or near the eyes; close eyes when product is being applied do not permit contact with mucus membranes, such as inside the nose, mouth or vagina, as irritation or stinging may occur tingling may occur during the first 10 minutes of application; this is normal and should go away; if it doesn't, rinse hair immediately and discontinue use
Dosage and Administration:
Directions adults and children 6 months and older: shake well before each use hold bottle 4-6 " from head; spray on dry hair and entire scalp, starting at the hairline and working inward toward the crown thoroughly saturate all hair and scalp; to be effective all lice and nits must come in full contact with the product dead lice and nits may be removed with a fine tooth comb, if desired for best results, allow product to air dry naturally, do not rinse out product may be used as often as desired; washing hair regularly is recommended to aviod product build-up for body and crab lice, spray on affected areas and let dry children under 6 months of age: do not use; consult a doctor
Stop Use:
Stop use and ask a doctor if skin irritation or infection is present or devleops
Package Label Principal Display Panel:
Lf uf kit
Further Questions:
Questions? call 1-800-482-4464. serious side effects may be reported to this number.