Label: QUIT NITS ADVANCE- quassia amara cream

  • 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 30, 2009

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

  • ACTIVE INGREDIENTS

    Quassia amara 2X HPUS (Amargo 200mcg/g)

  • PURPOSE

    Lice and egg treatment

  • USE

    treats head lice, pubic (crab lice) and body lice
  • WARNINGS

    For external use only.

    DO NOT USE

    • near eyes
    • inside the nose, mouth or vagina
    • on lice in eyebrows or eyelashes

    See a doctor if lice are present in these areas.



    WHEN USING THIS PRODUCT

    • keep tightly closed and protect eyes with a washcloth or towel.
    • if product gets into the eyes, flush with water right away.

    STOP USE AND ASK A DOCTOR IF

    • eye irritation occurs
    • skin or scalp irritation continues or infection occurs



    KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Important: Read warnings and full directions. For more information read the enclosed Consumer Information Leaflet.
    For adults and children 6 months and over.

    APPLY
    • apply the entire contents of one tube thoroughly to dry hair, starting from behind the ears to the back of the neck, working forward.
    • to be effective, all lice and eggs must come in contact with product, ensure hair and scalp are saturated. For long or very thick hair two tubes may be required.
    COVER
    • use the shower cap supplied to keep hair damp, leave on for 4 hours before washing.
    • for serious infestation remove shower cap after 4 hours and leave product on overnight.
    WASH
    • wash area thoroughly with warm water and regular shampoo. Towel hair dry and comb out tangles using a regular comb or brush.
    • as an option remove any remaining lice or nits with the included nit comb or fingernails.
    • if hair dries during combing dampen slightly with water.
  • OTHER INFORMATION

    • keep carton for important product information
    • protect from excessive heat
  • STORAGE AND HANDLING


  • INACTIVE INGREDIENTS


    aqua, cetearyl alcohol, dimethicone, fragrance, cetrimonium bromide, citric acid
  • QUESTIONS

    800-961-4936 or

    support@QuitNits.com

    www.QuitNits.com

  • PACKAGING INFORMATION

    Quit Nits®
    Caring for your child, naturally

    2.03 FL  OZ (60mL)

    ADVANCE
    Kills head lice and eggs with one application

    WILD CHILD®
    Born, not made.

    Ingredients Incl: Aqua, cetearyl alcohol, dimethicone, fragrance, cetrimonium bromide, citric acid, quassia wood jamaican extract.
    4 simple steps to help eliminate Head Lice Infestation:

    APPLY - Massage cream through dry hair and onto scalp, ensuring all of the hair and the back of the neck is wet with product.

    COVER - Use shower cap supplied to keep hair damp and leave on for 4 hours. For serious infestation remove cap and leave treatment on overnight.

    WASH - after 4 hours use your regular shampoo to remove the product. Any remaining lice and eggs should be removed with fingernails.

    FOLLOW-UP try Quit Nits Every Day Lice Preventative Spray to limit re-infestation.

    For external use only. Avoid contact with eyes. If product gets into eyes, rinse well with water. If irritation occurs, discontinue use.

    Manufactured for:
    Wild Child (US) Pty Ltd
    by The Triad Group
    Hartland, WI 53029
    info@wildchildonline.com
    800.961.4936

    For batch and expiry date see crimp

    tube



  • INGREDIENTS AND APPEARANCE
    QUIT NITS ADVANCE 
    quassia amara cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30807-2002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    quassia (UNII: S5249Q85HW) (quassia - UNII:S5249Q85HW) quassia2 [HP_X]  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    dimethicone (UNII: 92RU3N3Y1O)  
    cetrimonium bromide (UNII: L64N7M9BWR)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30807-2002-260 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2008
    Labeler - Wild Child W A Pty Ltd (744660692)
    Registrant - Wild Child W A Pty Ltd (744660692)
    Establishment
    NameAddressID/FEIBusiness Operations
    Triad Group050259597manufacture