Liendrex

Liendrex
SPL v3
SPL
SPL Set ID 65f86a0d-0cf7-42f6-84de-4dc9e7791aba
Route
TOPICAL
Published
Effective Date 2013-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Piperonyl Butoxide (4 g) Pyrethrum Extract (0.3 g)
Inactive Ingredients
Water Peg-20 Sorbitan Isostearate Cocamidopropyl Betaine Polysorbate 80 Sodium Trideceth Sulfate Sodium Lauroamphoacetate Sodium Laureth-13 Carboxylate Anhydrous Citric Acid Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-01-01

Description

ACTIVE INGREDIENTS PYRETHINS 0.30% PIPERONYL BUTOXIDE 4%


Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY.

Indications and Usage

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

Dosage and 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.
Contraindications

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

Description

ACTIVE INGREDIENTS PYRETHINS 0.30% PIPERONYL BUTOXIDE 4%

Section 50565-1

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

Section 50566-9

STOP USE AND ASK A DOCTOR IF

  • SKIN IRRITATION OR INFECTION IS PRESENT OR DEVELOPS.
  • INFESTED EYEBROWS OR EYELASHES OCCURS.
Section 50567-7

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.
Section 50570-1

DO NOT USE

  • NEAR OR PERMIT CONTACT WITH EYES OR MUCOUS MEMBRANES, SUCH AS INSIDE THE NOSE, MOUTH, OR VAGINA AS IRRITATION MAY OCCURE.
Section 51727-6

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.

Section 51945-4

Section 55105-1

PURPOSE

LICE TREATMENT

Section 55106-9

ACTIVE INGREDIENTS

PYRETHINS 0.30%

PIPERONYL BUTOXIDE 4%

Section 60561-8

OTHER INFORMATION

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

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.
Contraindications (34070-3)

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

Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF

  • SKIN IRRITATION OR INFECTION IS PRESENT OR DEVELOPS.
  • INFESTED EYEBROWS OR EYELASHES OCCURS.
Section 50567-7 (50567-7)

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.
Section 50570-1 (50570-1)

DO NOT USE

  • NEAR OR PERMIT CONTACT WITH EYES OR MUCOUS MEMBRANES, SUCH AS INSIDE THE NOSE, MOUTH, OR VAGINA AS IRRITATION MAY OCCURE.
Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

LICE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS

PYRETHINS 0.30%

PIPERONYL BUTOXIDE 4%

Section 60561-8 (60561-8)

OTHER INFORMATION

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

Advanced Ingredient Data


Raw Label Data

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