LIENDREX- pyrethrum extract, piperonyl butoxide shampoo

LIENDREX by

Drug Labeling and Warnings

LIENDREX by is a Otc medication manufactured, distributed, or labeled by Menper Distributors Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

PYRETHINS 0.30%

PIPERONYL BUTOXIDE 4%

PURPOSE

PURPOSE

LICE TREATMENT

INDICATIONS & USAGE

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

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY.

CONTRAINDICATIONS

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

DO NOT USE

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

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

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

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

OTHER INFORMATION

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIENDREX 
pyrethrum extract, piperonyl butoxide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-308
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 g  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV)	PYRETHRUM EXTRACT	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-308-04	120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358G	01/01/2013

Labeler - Menper Distributors Inc. (101947166)