LICEL- piperonly butoxide, pyrethrum extract oil

Licel by

Drug Labeling and Warnings

Licel by is a Otc medication manufactured, distributed, or labeled by Sujanil Chemo Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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 into 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

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

• 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 at time
• unlike dandruff which moves when touched, nits stick to the 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, fist apply behind ears and to back of neck.
• allow product to remain for a minimum 10 minutes.
  
• wash area throughly with warm water and soap or shampoo.
• for head lice, towel dry hair and comb out tangles.

Remove lice and their eggs (nits)

• use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).
• hair should remain slightly damp while removing nits
• if hair dries during combing, dampen slightly with water
• for head lice, part hair into sections. 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.
• pin back each strand of hair after combing.
• clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bad and discard to prevent lice from coming back.
• after combing, throughly recheck for lice/nits. Repeat combing if necessary.
• 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

Other Information

• store in cool and dry place
  
• keep carton for important product information
• see package insert for additional information.
  

Inactive ingredients

vegetables oil

QUESTIONS

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:

• Carefully inspect infested family member daily for at least 2 weeks. If you see eggs or nits, repeat step 2.
• Check other family members for Head Lice. If anyone in the family is infested, follow Step 1 and Step 2. Repeat Step 3 with any articles or items with which they have come in contact.

Second Application

• Report the same procedures within 7 - 10 days for

Step 1: Treat and Step 2: Remove

There may be some eggs that were not combed out after the first treatment. If infestation continues, see a doctor for other treatments. These eggs will hatch and need to be killed with the second treatment.

Did you know?

Head Lice

• Head lice lay small white eggs (nits) on hair shaft close to the scalp
• Nits are most easily found on back of neck or behind ears
• Disinfect hats, ribbons, scarves, coats, towels and bed linens by machine washing in hot water (above 54oC (130oF), then using 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 hot water (above 54oC (130oF) for at least 10 minutes
• Vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people.

Pubic (Crab) Lice

• Pubic Lice may be transmitted by sexual contact. Sexual partners should be treated simultaneously to avoid reinfestation.
• Pubic Lice are very small and look like brown or gray dots on skin.
• Pubic Lice usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface.
• Pubic Lice may be presented on the short hairs of groin, thighs, trunk and underarms and occasionally on the beard and mustache.
• Pubic Lice infested underwear can be disinfected by machine washing in hot water (above 54oC (130oF), then using hottest dryer cycle for at least 20 minutes.

Body Lice

• Body Lice and their eggs (nits) are generally found in the seams of clothing particularly in waistline and armpit area.
• Body Lice feed on skin then return to clothing to lay their eggs.
• Body Lice infested clothing can be disinfected by machine washing in hot water (above 54oC (130oF), then using the hottest dryer cycle for at least 20 minutes.
• Body Lice nits can remain dormant for up to 30 days and therefore clothing should not be sealed in a plastic bag
• Save this package insert for future reference.

STEP 1 TREAT

Licel Lice Treatment 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.

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 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 Licel Lice Treatment 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 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 10 minutes, but no longer (or other  affected area) for at least an hour.
• 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.

Usage Guidlines

Hair Length                Approximate 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                    :  2 oz – 4 oz

Long                               First Application          :   3 oz – 4 oz
(past shoulder length        Second Application     :   3 oz – 4 oz
                                      Total                    :  6 oz – 8 oz


The Licel comb is proven 100% effective as demonstrated in laboratory studies performed by trained testers, individual results my 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 ma 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 bad, seal the bad 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 54oC (130oF), 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 water (above 54oC (130oF) 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

NDC No.: 76441-902-97

Comb with Magnifier Included

India's leading Lice Killer

Sujanil

Maximum Strength
Licel
Lice Treatment Oil

Proven and tested in India
for more than 4 Decades now in USA

Manufactured By:
Sujanil Chemo Industries
P.O. Box No. 1451, Marketyard P.O.,
Pune - 411037 (M.S.) India

Carton Label

Bottle Label

Leaflet

INGREDIENTS AND APPEARANCE

LICEL 
piperonly butoxide, pyrethrum extract oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76441-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH)	PIPERONYL BUTOXIDE	4 mL  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV)	PYRETHRUM EXTRACT	0.33 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SESAME OIL (UNII: QX10HYY4QV)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76441-902-97	1 in 1 BOX
1		118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	06/20/2012

Labeler - Sujanil Chemo Industries (650280816)

Establishment
Name	Address	ID/FEI	Business Operations
Sujanil Chemo Industries		915896189	manufacture(76441-902)