Licefreee
Sodium Chloride
Tec Laboratories, Inc.
Human Otc Drug
NDC 51879-122Licefreee also known as Sodium Chloride is a human otc drug labeled by 'Tec Laboratories, Inc.'. National Drug Code (NDC) number for Licefreee is 51879-122. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Licefreee drug includes . The currest status of Licefreee drug is Active.
Drug Information:
| Drug NDC: | 51879-122 |
| 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 |
| 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: | Sodium Chloride |
| 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: | 13 Jul, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jun, 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. |
| 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 |
|---|
| 51879-122-88 | 1 KIT in 1 KIT (51879-122-88) * 227 g in 1 BOTTLE, PLASTIC (51879-121-80) * 236.6 mL in 1 BOTTLE, PLASTIC (51879-191-08) | 13 Jul, 2016 | 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 pediculosis remedy
Purpose pediculosis remedy
Product Elements:
Licefreee sodium chloride licefreee sodium chloride water cocamidopropyl betaine aminomethyl propanediol peg-6 caprylic/capric glycerides sodium chloride sodium cation carbomer homopolymer type c (allyl pentaerythritol crosslinked) anise oil licefreee everyday sodium chloride benzyl alcohol water cocamidopropyl betaine tea tree oil sodium chloride sodium cation polyquaternium-10 (125 mpa.s at 2%) edetate disodium sodium lauryl sulfate
Indications and Usage:
Uses use daily to help avoid head lice reinfestation.
Uses â for the treatment of â head lice â pubic (crab) lice â body lice
Warnings:
Warnings for external use only.
Warnings for external use only
When Using:
When using this product do not use in or near the eyes; close eyes while product is being applied do not permit contact with mucous membranes, such as inside the nose as irritation or stinging may occur
When using this product do not use in or near the eyes do not permit contact with mucous membranes, such as inside the nose, mouth, or vagina, as irritation or stinging may occur close eyes tightly while hair is being rinsed; do not open eyes until product is rinsed out tingling may occur during the first 10 minutes of application; this is normal and should go away; if it doesnât, rinse hair immediately and discontinue use
Dosage and Administration:
Directions adults and children 6 months and older: for best results on a head lice infestation, use licefreee spray!® or licefreee!® gel treatment before using this shampoo. apply a generous amount of shampoo to wet hair, work into a lather while massaging into scalp; rinse repeat, this time leaving the shampoo on the hair for 3 minutes; rinse use daily for at least 7-10 days to treat any lice that have hatched. children under 6 months: do not use; consult a doctor
Directions adults and children 6 months of age and older: shake well remove cap and tamper evident seal; replace with enclosed root applicator apply to dry hair and entire scalp, starting at the nape of the neck and behind ears (where lice congregate) and work forward thoroughly saturate all hair and scalp; to be effective, all lice and nits must come in full contact with the product put plastic cap on head and leave on for at least 60 minutes; for best results stay in a warm room never leave child unattended with plastic cap on with product still in hair, remove plastic cap and comb out all dead lice and nits with enclosed fine toothed comb; rinse comb out under running water once all lice and nits are combed out, rinse hair thoroughly with warm running water thoroughly inspect and comb hair and scalp a second time to ensure complete removal of all lice and nits licefreee! may be used as often as necessary; a second treatment in 7-10 days is recommended to kill any newly hatched lice
Read more...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 develops
Stop use and ask a doctor if skin irritation or infection is present or develops
Package Label Principal Display Panel:
Ndc 51879-122-88 original non-toxic licefreee! kit includes: licefreee!® gel head lice treatment licefreee® everyday! shampoo kills super lice and eggs mata piojos y liendres shampoo helps avoid lice reinfestation with daily use ayuda y evitar infestación de piojos al usarse diariamente homeopathic homeopática contents: homeopathic homeopática contents: licefreee gel net wt 8 oz (227g) licefreee shampoo net 8 fl oz (236.6 ml) professional nit comb piene profesional para liendres lfk
Further Questions:
Questions? call 1-800-482-4464. serious side effects may be reported to this number.
Questions? call 1-800-482-4464. serious side effects can be reported to this number.