Label: LICE-NIL LICE AND EGGS ELIMINATOR OIL- azadirachta indica oil

  • NDC Code(s): 76441-909-94
  • Packager: Sujanil Chemo Industries
  • 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 August 24, 2017

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

  • Drug Facts

  • Active Ingredients

    Azadirachta Indica (NEEM) 1X

  • Purpose

    Lice treatment.

  • Uses:

    Treats head lice/nits, pubic lice (crab) and body lice

  • Warnings

    For External Use Only

    Do not use:

    • Near eyes
    • Inside nose, mouth or vagina
    • On lice in eyebrows or eyelashes. See a doctor if lice are present in these areas

    Ask a Doctor before use if you are:

    • Allergic to ragweed. May cause breathing difficulty or an asthmatic attack

    When using this product:

    • If product gets in eyes, flush with water right away

    Stop use and ask a doctor if:

    • Breathing difficulty occurs
    • Eye irritation occurs
    • Skin or scalp irritation or infection occurs
  • 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

    • Important: Read warnings before use
    • For Adults and Children 2 years and older
  • Directions

    Inspect

    • Check each household member with a magnifying glass in bright light for lice/nits (eggs)
    • Look for tiny nits near scalp, beginning at back of neck and behind ears
    • Examine small sections of hair at a time
    • Unlike dandruff which moves when touched, nits stick to the roots of hair
    • If either lice or nits are found, treat with this product

    Treat

    • Apply thoroughly to dry hair or other affected area. For head lice, first apply on hair behind ears and back of neck, then continue to apply to the remainder of hair
    • Leave product on hair for a minimum of 20 minutes
    • Wash area thoroughly with warm water and shampoo or soap after treatment
    • For head lice, towel dry hair and comb out tangles

    Remove lice and their eggs (nits)

    • Using a fine-tooth comb or special lice/nit comb, remove any remaining nits by hand.
    • For head lice, part hair into sections and inspect one section at a time, starting at the top of head. Longer hair may take 1-2 hours.
    • Lift a 1-2-inch wide strand of hair. Place comb with a firm, even motion away from scalp.
    • Pin back each strand of hair after combing
    • Clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back
    • After combing, thoroughly recheck for lice/nits. Repeat combing if necessary
    • Check daily for any lice/nits that may have been missed
    • We recommend a second treatment after 7-10 days to kill any newly hatched lice
    • Children under 2 years: Consult with a Doctor or Physician
  • Other information

    • Shake well before use
    • Store in cool and dry place
    • Keep carton for important product information
    • See package insert for additional information
  • Inactive ingredients:

    Coconut Oil, Sesame Oil, Tea Tree Oil, Sunflower Oil with Herbal Extracts and Perfumes

  • Questions or comments?

    855-KIL-LICE - 855-545-5423

    www.licenil.com or e-mail: sales@sujanil.com

  • SPL UNCLASSIFIED SECTION

    'Lice-Nil' Lice & Eggs Eliminator Oil will kill lice completely without leaving a chemical residue. The amount of lice treatment oil needed will vary depending on hair length. See below for guidelines:

    Hair LengthApproximate Amount for 1 Adult/Child:
    Short First Application: 1 oz - 2 oz
    (ear length or shorter)Second Application: 1 oz - 2 oz
    Total: 2 oz - 4 oz
    Medium First Application: 2 oz - 3 oz
    (shoulder length)Second Application : 2 oz - 3 oz
    Total : 4 oz - 6 oz
    Long First Application: 3 oz - 4 oz 
    (past shoulder length)Second Application: 3 oz - 4 oz 
    Total  : 6 oz - 8 oz 

    The 'Lice-Nil' comb is proven 100% effective as demonstrated in laboratory studies performed by trained testers, individual results may vary.

  • SPL UNCLASSIFIED SECTION

    'Lice-Nil' Lice & Eggs Eliminator Oil

    Lice Treatment

    • Nothing Proven More Safe & Effective
    • Leaves No Chemical Residue Behind
    • One-Step, Easy-To-Use, Oil Based Application

    Lice-Nil 1-2-3 LICE ELIMINATION SYSTEM

    Step 1 Head Lice

    • Head lice lay small, white eggs (nits) on the hair shaft near the scalp.
    • Nits are most easily found on the back of the neck or behind the ears.
    • Disinfect hats, hair ribbons, clothing, scarves, coats, towels and bed linens by machine washing in hot water (above 54°C (130°F)), then dry using the hottest dryer cycle for at least 20 minutes.
    • Items that cannot be washed (pillows, stuffed toys, etc.) should be dry-cleaned or sealed in a plastic bag for 4 weeks. After 4 weeks, remove them from the plastic bag outdoors and shake rigorously before using again
    • Items that cannot be washed, dry-cleaned or stored may be sprayed with a product designed for purpose
    • Soak all combs and brushes in hot water (above 54°C (130°F)) for at least 10 minutes
    • Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by affected people.

    Step 2 Pubic (Crab) Lice

    • Pubic lice may be transmitted by sexual contact
    • Sexual partners should be treated simultaneously to avoid reinfestation
    • Pubic lice usually cause intense itching and lay small white eggs (nits) on the hair shaft, near the skin surface
    • Pubic lice may be present on the groin, thighs, trunk, underarms and occasionally on the beard and mustache
    • Disinfect underwear by machine washing in hot water (above 54°C (130°F)), then use hottest dryer cycle for at least 20 minutes

    Step 3 Body Lice

    • Body lice and their eggs (nits) are generally found in the seams of clothing, particularly in the waistline and armpit area
    • Body lice feed on skin then return to clothing to lay their eggs
    • Disinfect clothing by machine washing in hot water (above 54°C (130°F)), then use hottest dryer cycle for at least 20 minutes
    • Do not seal clothing in plastic bag because nits can remain dormant for up to 30 days
  • SPL UNCLASSIFIED SECTION

    ALL NATURAL

    SUPER LICE KILLER

    CLINICALLY PROVEN

    100% NATURAL ACTIVES

    WITH NEEM AND TEA TREE OIL

    The Power of NEEM Kills Lice & Eggs Completely in Just 20 Minutes

    Comb with Magnifier Included

    Chemical-Free, Lice-Free, Worry-Free

    A PRODUCT OF INDIA

    Manufactured By:

    sujanil chemo industries

    425/27, T.M.V. Colony, Pune 411 037 (INDIA)

    Imported by:

    Global Tradelinks

    4337, Austonway, Palm Harbour,

    FL 34685, USA

    Tel. : 1-727-359-1173, Fax : 1-813-886-3881,

    E-mail : jay@sujanil.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    LICE-NIL LICE AND EGGS ELIMINATOR OIL 
    azadirachta indica oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76441-909
    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 OIL1 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SESAME OIL (UNII: QX10HYY4QV)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    LEMON OIL (UNII: I9GRO824LL)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76441-909-941 in 1 CARTON08/01/2017
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2017
    Labeler - Sujanil Chemo Industries (650280816)