Label: LICE ICE- neem oil, tea tree oil gel

  • 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 March 23, 2020

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  • ACTIVE INGREDIENTS

    NEEM OIL.....0.937 X

    TEA TREE OIL.....0.937 X

  • PURPOSE

    LICE TREATMENT

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • USES

    TREATS HEAD LICE

  • DIRECTIONS

    TREATMENT: APPLY LICE ICE GEL GENEROUSLY TO DRY HAIR. MASSAGE WELL DOWN INTO SCALP AND ROOTS, MAKING SURE TO GET ALL THE HAIR ENCASSED IN THE GEL. ALLOW LICE ICE TO AIR DRY COMPLETELY. LEAVE ON 12 TO 15 HOURS. DO NOT COVER THE HAIR. IF PROPERLY APPLIED, ALL LICE AND EGGS WILL BE ENTIRELY ENCASED IN A HARDENED GEL, MAKING IT IMPOSSIBLE FOR LICE TO FEED, LAY EGGS, OR FOR EGGS TO HATCH. VIGOROUSLY SHAMPOO WITH REGULAR SHAMPOO, RINSE WELL. DRY HAIR. THOROUGHLY INSPECT HAIR AND SCALP, REAPPLY IF NECESSARY.

    PREVENTATIVE:

    USE LICE INE IN PLACE OF DAILY STYLING GEL ON WET OR DRY HAR OR DILUTE LICE ICE GEL 1:4 IN WATER AND APPLY TO WET OR DRY HAIR AND SCALP AS A SPRAY. REINFESTATION IS LIKELY IF THE LIVING ENVIRONMENT HAS NOT BEEN CLEANED. PLEASE VISIT WWW.LICEICE.COM FOR MORE INFO.

  • INGREDIENTS:

    PURIFIED WATER, SD ALCOHOL, PVP/VA COPOLYMER, POLYQUATERNIUM 11, TRAGACANTH GUM, DIMETHICONE COPOLYOL, CARBOMER 940, TRIETHANOLAMINE, EMPIRE ORGANICS SPECIAL BLEND OF NEEM, TEA TREE, LEMON, LAVENDER, THYME AND ROSEMARY ESSENTIAL OILS, FD&C BLUE NO. 1, FRAGRANCE, BENZOPHENONE 4.

  • PRINCIPAL DISPLAY PANEL

    Lice Ice Label 4oz

  • INGREDIENTS AND APPEARANCE
    LICE ICE 
    neem oil, tea tree oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69170-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) (AZADIRACHTA INDICA SEED OIL - UNII:4DKJ9B3K2T) AZADIRACHTA INDICA SEED OIL0.937 [hp_X]  in 100 mL
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL0.937 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEMON OIL (UNII: I9GRO824LL)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    THYME OIL (UNII: 2UK410MY6B)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    TRAGACANTH (UNII: 2944357O2O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69170-102-14118 mL in 1 TUBE; Type 0: Not a Combination Product03/22/2020
    2NDC:69170-102-18236 mL in 1 TUBE; Type 0: Not a Combination Product03/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/2014
    Labeler - NATURALRX LLC (152081183)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIVERSIFIED MANUFACTURING CORP185073996manufacture(69170-102)
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