Label: X-PEL ANTI-LICE- apis mellifica, carbolicum acidum, ledum palustre shampoo

  • 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 May 2, 2014

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

  • ACTIVE INGREDIENT

    Active Ingredients

    Apis Mellifica 15x

    Carbolicum Acidum 15x

    Ledum Palustre 15x

  • PURPOSE

    NON-TOXIC

    Professional Formula

    X-PEL™

    Anti-Lice Shampoo & Conditioner

    • Eliminates Lice
    • Works in Just 10 Minutes
    • Stops Itching
    • Eases Egg Removal
    • Leaves Hair Soft, Shiny & Tangle-Free
    • Repels Lice
    • Pediatrician and Dermatologist Approved

    6 fl. oz. (177 mL)

    NDC 11727-6-06

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indications

    For treatment of pediculosis.

    • Eliminates Lice
    • Makes eggs easy to remove
    • Stops itching caused by lice bites
  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes.

    If eye contact occurs, rinse with clear water.

    Keep out of reach of children.

    Safe for ragweed sufferers.

  • DOSAGE & ADMINISTRATION

    Directions

    SHAKE WELL BEFORE USE

    1. Wet hair with warm water.

    2. Apply X-PEL™ liberally and massage into wet hair until a thick lather forms.

    3. Leave lather on hair for 10 minutes. Do not rinse.

    4. Divide hair into sections and comb with the NitPro-II™ comb to remove lice and eggs. Rinse comb after each stroke. For instructions on how to use the comb read the insert inside the box.

    5. Rinse hair with warm water. Repeat steps 2-4.

    6. Finally, rinse the hair with warm water, towel dry and inspect for and comb out any remaining eggs. Clean comb with hot water and store for future use.

  • INACTIVE INGREDIENT

    Other ingredients

    water, cocamidopropyl betaine, pyroligeneous acid purified (USP), amodiemethicone & tallowtrinionium chloride & nonoxynol-10, glycerin (USP), ethylene glycol distearate, polyquaternium-10, fragrance, diazolidinyl urea, methylparaben, proplyparaben, tetrasodium EDTA, FD&C blue no.1, FD&C yellow no.5

  • OTHER SAFETY INFORMATION

    Cruelty Free Testing

    Environmentally Safe

    Homeopathic Formula

    Distributed By: Dermedics Laboratories

    335 Sniffen Lane, Stratford, CT 06615

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    X-PEL ANTI-LICE 
    apis mellifica, carbolicum acidum, ledum palustre shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11727-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA15 [hp_X]  in 170 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL15 [hp_X]  in 170 g
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG15 [hp_X]  in 170 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PYROLIGNEOUS ACID (UNII: N4G9GAT76C)  
    AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11727-006-06170 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/15/2014
    Labeler - Dermedics Laboratories (124151494)
    Establishment
    NameAddressID/FEIBusiness Operations
    Briangeli Beauty Enterprises010656161manufacture(11727-006)