LIENDREX- pyrethrum extract, piperonyl butoxide shampoo 
Menper Distributors Inc.

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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ACTIVE INGREDIENTS

PYRETHINS 0.30%

PIPERONYL BUTOXIDE 4%

PURPOSE

LICE TREATMENT

USES: FOR THE TREATMENT OF HEAD, BODY, PUBIC (CRAB) LICE.

WARNINGS

FOR EXTERNAL USE ONLY.

ALLERGY ALERT: USE WITH CAUTION ON PERSONS WITH ALLERGIC TO RAGWEED.

DO NOT USE

  • NEAR OR PERMIT CONTACT WITH EYES OR MUCOUS MEMBRANES, SUCH AS INSIDE THE NOSE, MOUTH, OR VAGINA AS IRRITATION MAY OCCURE.

WHEN USING THIS PRODUCT

  • KEEP OUT OF EYES WHEN RINSING HAIR.
  • CLOSE EYES TIGHTLY AND DO NOT OPEN UNTIL PRODUCT IS RINSED OUT.
  • PROTECT EYES WITH WASHCLOTH, TOWEL OR OTHER SUITABLE MATERIAL OR BY SIMILAR METHOD.
  • IF PRODUCT GETS INTO EYES, IMMEDIATELY FLUSH WITH WATER.

STOP USE AND ASK A DOCTOR IF

  • SKIN IRRITATION OR INFECTION IS PRESENT OR DEVELOPS.
  • INFESTED EYEBROWS OR EYELASHES OCCURS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

IMPORTANT: READ WARNINGS AND OTHER INFORMATION BEFORE USING.

  • SHAKE WELL BEFORE USING.
  • USE ON DRY HAIR.
  • APPLY TO AFFECTED AREA UNTIL ALL HAIR IS THOROUGHLY WET WITH PRODUCT.
  • ALLOW PRODUCT TO REMAIN ON FOR 10 MINUTES BUT NO LONGER.
  • ADD SUFFICIENT WARM WATER TO FORM A LATHER AND SHAMPOO AS USUAL.
  • RINSE THOROUGHLY.
  • A FINE TOOTH COMB OR SPECIAL LICE/NIT-REMOVAL COMB MAY BE USED TO HELP REMOVE DEAD LICE AND THEIR EGGS (NITS) FROM HAIR.
  • A SECOND TREATMENT MUST BE DONE IN 7 TO 10 DAYS TO KILL ANY NEWLY HATCHED LICE.

OTHER INFORMATION

  • STORAGE: PROTECT FROM FREEZING AND EXCESSIVE HEAT.
  • DO NOT REUSE ORIGINAL CONTAINER.

OTHER INGREDIENTS

WATER, PEG-80 SORBITAN LAURATE, COCAMIDOPROPYL BETAINE, POLYSORBATE 80, SODIUM TRIDECETH SULFATE, SODIUM LAUROAMPHOACETATE, SODIUM LAURETH-13 CARBOXYLATE, CITRIC ACID AND TETRASODIUM EDTA.

Linendrex Label Artwork

LIENDREX 
pyrethrum extract, piperonyl butoxide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-308
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 EXTRACT0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PEG-20 SORBITAN ISOSTEARATE (UNII: X958PZJ9ON)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM TRIDECETH SULFATE (UNII: E827ILX331)  
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
SODIUM LAURETH-13 CARBOXYLATE (UNII: 795TQP1655)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-308-04120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358G01/01/2013
Labeler - Menper Distributors Inc. (101947166)

Revised: 3/2013
 
Menper Distributors Inc.