Liendrex Shampoo
FDA Label NDC 53145-308

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Liendrex (NDC 53145-308). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, contraindications, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS

PYRETHINS 0.30%

PIPERONYL BUTOXIDE 4%

Otc - 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.

Otc - 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.

Otc - 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.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF

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

Otc - 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.

* Please review the disclaimer below.