LICE-NIL LICE AND EGGS KILLER- piperonly butoxide, pyrethrum extract oil 
Sujanil Chemo Industries

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lice-Nil Lice & Eggs Killer Oil

Drug Facts

Active ingredients

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

Lice Treatment

Uses

treats head, pubic (crab), and body lice

Warnings

For external use only

Do not use

Ask a doctor before use if you are:

When using this product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Shake well before using

Important: Read warnings before use

adults and children 2 years and over:

Inspect

Treat

Remove lice and their eggs (nits)

Other Information

Inactive ingredients

vegetable oils

Questions or comments?

855-KIL-LICE - 855-545-5423
www.sujanil.com or e-mail: sales@sujanil.com

Package Insert

DAILY CHECKING

TO PREVENT REINFESTATION:

Second Application

Step 1: Treat and Step 2: Remove

Did you know?

Head Lice

Pubic (Crab) Lice

Body Lice

STEP 1 TREAT

Lice-Nil Lice & Eggs Killer Oil

Steps to Success

with 1-2-3 Lice Control System

Complete Lice Control for your family and home.

SHAKE WELL BEFORE USING

DIRECTIONS: IMPORTANT: READ WARNINGS BEFORE USING. A SECOND TREATMENT MUST BE DONE IN 7-10 DAYS TO KILL ANY NEWLY HATCHED 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

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets in eyes, flush with water right away
  • scalp itching or redness may occur

Stop use and ask a doctor if

  • breathing difficulty occurs
  • 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

See Usage Guidelines below to estimate how much product you will need.

Usage Guidelines 
 Hair LengthApproximate Amount for 1 Adult/Child:

Short (ear length or shorter)

  First Application      : 1 oz - 2 oz

  Second Application : 1 oz - 2 oz

Total                      : 2 oz - 4 oz

Medium (shoulder length)

  First Application      : 2 oz - 3 oz

  Second Application : 2 oz - 3 oz

Total                      : 4 oz - 6 oz

Long (past shoulder length)

  First Application      : 3 oz - 4 oz

  Second Application : 3 oz - 4 oz

Total                      : 6 oz - 8 oz

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 time
  • unlike dandruff which moves when touched, nits stick to the hair
  • if either lice or nits are found, treat with this product

NOTE:

  • Use towels to protect child's eyes from treatment. Ask the child to keep eyes tightly closed.
  • Apply 'Lice-Nil' Lice & Eggs Killer Oil thoroughly to DRY HAIR or other affected area.
  • Wetting the hair dilutes the treatment making it less effective.
  • Also lice can hold their breath when immersed in water making it difficult for the active ingredient to penetrate the lice
  • For head lice, thoroughly massage oil into scalp, behind the ears and to the back of the neck. Lice can crawl up and down the shaft of the hair very quickly so it is important to apply the treatment from the roots to the ends of the hair.
  • Allow product to remain for minimum 10 minutes.
  • Wash area thoroughly with warm water and soap or shampoo
  • For head lice, towel dry hair and comb out tangles
  • Proceed to Step 2.
  • A second treatment must be done in 7 to 10 days to kill any newly hatched lice.

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

STEP 2 REMOVE

NOTE:

  • A fine - toothed come or special lice / nit removing comb (included) must be used to remove lice, eggs, and nits from hair.
  • Before starting have on hand:

     - extra towels

     - bobby pins or hair clips

     - facial tissues or paper towels

     - regular comb for parting and detangling hair

     - throw-away gloves

  • Find a distraction for your child (e.g. books, TV, game)
  • Comb out hair with a regular wide-tooth comb to take out snarls and tangles.
  • When combing, use the fine-toothed lice/nit comb provided and make sure the teeth are facing you.
  • Part hair into section. Do one section at a time. Starting on top of the head. Longer hair may take 1 to 2 hours.
  • Lift a 1- to 2- inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.
  • Always comb away from the head.
  • Pin back each strand of hair after combing.
  • Wipe eggs and nits from the teeth of the comb with a tissue or paper towel often.
  • Remove any remaining nits by hand (using a throw-away glove)
  • Discard all the used tissue or cloths into bag, seal the bag and dispose of immediately to prevent lice from coming back.
  • After combing, throughly recheck for lice/nits. Repeat combing if necessary
  • After you have combed and pinned the entire head, remove all bobby pins or hair clips and thoroughly recheck for lice/nits. Repeat combing if necessary.
  • Rinse hair thoroughly with warm water, If desired, you may also wash with regular shampoo.
  • Check daily for any lice/nits that you missed.
  • A second treatment must be done in 7 to 10 days to kill any newly hatched lice.
  • If infestation continues, see a doctor for other treatments.
  • Children under 2 years: Ask a doctor

STEP 3 CONTROL

  • Head lice lay small white eggs (nits) on the hair shaft close to the scalp
  • Nits are most easily found on the back of the neck or behind the ears
  • Disinfect hats, hair ribbons, scarves, coats, towels and bed linens by machine washing in hot water (above 54°C (130°F)), then using the hottest dryer cycle for at least 20 minutes.
  • Items that cannot be washed (bedspreads, blankets, pillows, stuffed toys, etc.) should be dry-cleaned or sealed in a plastic bag for 4 weeks, then removed outdoors and shaken out very hard before using again
  • Items that cannot be washed, dry-cleaned, or stored may be sprayed with a product designed for this purpose
  • Soak all combs and brushes in to 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.

CHECKLIST

  • Home and auto upholstery
  • Pillows, pillowcases, mattresses
  • Bed Linen
  • Towels
  • Stuffed animals toys
  • Hats
  • Headphones
  • Headbands
  • Bike/sports helmets
  • Coats, gloves, scarves, earmuffs
  • Pay mats
  • Clothing
  • Barettes/Hair ornaments
  • Hair rollers
  • Combs and brushes
  • Baseball caps

Principal Display Panel

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LICE-NIL  LICE AND EGGS KILLER
piperonly butoxide, pyrethrum extract oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76441-903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE4 g  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.33 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV)  
COCONUT OIL (UNII: Q9L0O73W7L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76441-903-971 in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G06/18/2013
Labeler - Sujanil Chemo Industries (650280816)
Establishment
NameAddressID/FEIBusiness Operations
Sujanil Chemo Industries915896189manufacture(76441-903)

Revised: 11/2014
Document Id: dbfbc2a6-6e3b-4aff-bf91-3747563a1f5a
Set id: 0e52fa83-404e-45fc-ac91-23445e369ecf
Version: 4
Effective Time: 20141106
 
Sujanil Chemo Industries