Label: LICEFREEE AFTERLICE- pramoxine hci spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient

    Pramoxine HCI 1%

  • WARNINGS

    For external use only

  • WHEN USING

    When using this product

    • avoid contact with eyes
  • STOP USE

    Stop use and ask a doctor if

    • condition worstens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • 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.
  • STORAGE AND HANDLING

    Other Information

    Store at 59-86ºF (15-30ºC)

  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, benzethonium CI, menthol, panthenol, polyoxyl 35 castor oil, polyquaternium-10, purified water, tea tree oil

  • QUESTIONS

    Questions or comments?

    Call 1-800-482-4464.

  • INDICATIONS & USAGE

    Uses

    for the temporary relief of itching associated with

    • insect bites
    • minor skin irritations
  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years of age and older: spray on affected area not more than 3-4 times daily
    • Children under 2 years; do not use; consult a doctor

  • PURPOSE

    Pain and itch relief spray for scalp irritation caused by lice bites and lice treatments.

  • PRINCIPAL DISPLAY PANEL

    Licefreee AfterLice

  • INGREDIENTS AND APPEARANCE
    LICEFREEE AFTERLICE 
    pramoxine hci spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51879-260-06177.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/16/2023
    Labeler - Tec Laboratories Inc. (083647792)
    Registrant - Tec Laboratories Inc. (083647792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tec Laboratories Inc.083647792manufacture(51879-260)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!