LICEL - 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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Licel Lice Treatment 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:

allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

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

vegetables oil

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

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

Pubic (Crab) Lice

Body LiceSTEP 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:


Ask a doctor before use if you are

When using this product

Stop use and ask a doctor if

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

Inspect Note:


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:



Step 3 Control


CHECKLIST



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

Carton Label


Bottle Label

Bottle Label


Leaflet

Leaflet


LICEL 
piperonly butoxide, pyrethrum extract oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76441-902
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE4 mL  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.33 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV)  
COCONUT OIL (UNII: Q9L0O73W7L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76441-902-971 in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G06/20/2012
Labeler - Sujanil Chemo Industries (650280816)
Establishment
NameAddressID/FEIBusiness Operations
Sujanil Chemo Industries915896189manufacture(76441-902)

Revised: 9/2012
Document Id: 7cd2f3b6-3b50-4a00-99d5-86d7dd298efa
Set id: e165d005-2275-4f22-a6ac-fd5778e6f6c4
Version: 2
Effective Time: 20120914
 
Sujanil Chemo Industries