Label: LICEFREEE- sodium chloride kit

  • NDC Code(s): 51879-121-80, 51879-122-88, 51879-191-08
  • Packager: Tec Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 2, 2023

If you are a consumer or patient please visit this version.

  • Licefreee Shampoo Everyday!

    Active Ingredient

    Natrum muriaticum 1X 10% HPUS (Sodium chloride)

  • PURPOSE

    Purpose

    Pediculosis remedy

  • INDICATIONS & USAGE

    Uses

    • Use daily to help avoid head lice reinfestation.
  • WARNINGS

    Warnings

    For external use only.

  • ASK DOCTOR

    Ask a doctor before use if you

    • have infestation of eyebrows or eyelashes
    • are pregnant

  • 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

  • STOP USE

    Stop use and ask a doctor if

    • skin irritation or infection is present or develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • if swallowed, get medical help or contact a Poison Control Center right away
  • DOSAGE & 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
  • STORAGE AND HANDLING

    Other information

    store at 59-86°F (15-30°C)

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzyl alcohol, cocamidopropyl betaine, disodium EDTA, fragrances, polyquaternium 10, purified water, sodium lauryl sulfate, tea tree oil

  • QUESTIONS

    Questions?

    Call 1-800-482-4464. Serious side effects may be reported to this number.

  • Licefreee! Gel Lice Treatment

    Active Ingredient

    Natrum muriaticum 1X 10% HPUS (Sodium chloride)

  • PURPOSE

    Purpose

    Pediculosis remedy

  • INDICATIONS & USAGE

    Uses

    ■For the treatment of ■ head lice ■ pubic (crab) lice ■ body lice

  • WARNINGS

    Warnings

    For external use only

  • ASK DOCTOR

    Ask a doctor before use if you have

    • infestation of eyebrows or eyelashes
  • WHEN USING

    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
  • STOP USE

    Stop use and ask a doctor if

    • skin irritation or infection is present or develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • if swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    Other Information​

    Store at 59 - 86°F (15 - 30°C)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    aminomethyl propanol, anise oil, carbomer, cocamidopropyl betaine, fragrance, PEG-6 caprylic/capric glycerides, purified water

  • QUESTIONS

    Questions?

    Call 1-800-482-4464. Serious side effects can be reported to this number.

  • PRINCIPAL DISPLAY PANEL

    LFKNDC 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

  • INGREDIENTS AND APPEARANCE
    LICEFREEE 
    sodium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-122
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51879-122-881 in 1 KIT; Type 1: Convenience Kit of Co-Package07/13/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE, PLASTIC 1 g
    Part 20 BOTTLE, PLASTIC 1 mL
    Part 1 of 2
    LICEFREEE 
    sodium chloride gel
    Product Information
    Item Code (Source)NDC:51879-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ANISE OIL (UNII: 6Y89129C8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51879-121-80227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/30/2016
    Part 2 of 2
    LICEFREEE EVERYDAY 
    sodium chloride shampoo
    Product Information
    Item Code (Source)NDC:51879-191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51879-191-08236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/13/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/13/2016
    Labeler - Tec Laboratories, Inc. (083647792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tec Laboratories, Inc.083647792manufacture(51879-122)