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Licefreee - Medication Information

Product NDC Code 51879-122
Drug Name

Licefreee

Type Brand
Route TOPICAL
Dosage Form KIT
Labeler Name Tec Laboratories, Inc.
Packages
Package NDC Code Description
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)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Licefreee Shampoo Everyday! Active Ingredient Natrum muriaticum 1X 10% HPUS (Sodium chloride) Licefreee! Gel Lice Treatment Active Ingredient Natrum muriaticum 1X 10% HPUS (Sodium chloride)

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 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 children under 6 months of age: do not use, consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzyl alcohol, cocamidopropyl betaine, disodium EDTA, fragrances, polyquaternium 10, purified water, sodium lauryl sulfate, tea tree oil Inactive Ingredients aminomethyl propanol, anise oil, carbomer, cocamidopropyl betaine, fragrance, PEG-6 caprylic/capric glycerides, purified 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 Use daily to help avoid head lice reinfestation. Uses ■For the treatment of ■ head lice ■ pubic (crab) lice ■ body lice

Purpose

Information about the drug product’s indications for use.
Purpose Pediculosis remedy Purpose Pediculosis remedy

Spl product data elements

Usually a list of ingredients in a drug product.
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

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.
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

Recent major changes

A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.
repeat this time leaving the shampoo on the hair 3 minutes

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have infestation of eyebrows or eyelashes are pregnant Ask a doctor before use if you have infestation of eyebrows or eyelashes

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 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? 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.

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 skin irritation or infection is present or develops Stop use and ask a doctor if skin irritation or infection is present or develops

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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 doesn’t, rinse hair immediately and discontinue use

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 59-86°F (15-30°C) Other Information​ Store at 59 - 86°F (15 - 30°C)

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. Warnings For external use only

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