Application Nr Approved Date Route Status External Links
ANDA088191 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Lindane Shampoo Is Indicated For The Treatment Of Head Lice (Infestations Of Pediculus Humanus Capitis ), Crab Lice (Infestations Of Pthirus Pubis ), And Their Ova Only In Patients Who Cannot Tolerate Other Approved Therapies, Or Have Failed Treatment With Other Approved Therapies. Lindane Shampoo Should Be Used In The Context Of An Overall Lice Management Program That Includes: Visual Inspection To Ensure That The Patient Is Currently Infested With Live Lice (Empty Egg Casings Or "nits" Can Remain On Hair Shaft Long After True Infestation). Manual Removal Of Nits Using A Comb Designed For This Purpose And/or Individual Removal With Tweezers Followed By Close Examination Of The Hair And Scalp. Evaluation And Treatment Of Sexual Contacts Simultaneously. Sexual Contacts Should Be Prescribed Lindane Shampoo Only If They Either Have Failed To Respond To Adequate Doses Of Other Approved Therapies Or Are Intolerant Of Other Approved Therapies. All Recently Worn Clothing, Underwear, Pajamas, Used Sheets, Pillowcases, And Towels Should Be Washed In Very Hot Water Or Dry-Cleaned. Caregivers Applying This Product To Patients Should Wear Gloves Less Permeable To Lindane Such As Nitrile, Latex With Neoprene Or Sheer Vinyl, And Thoroughly Clean Hands After Application. Natural Latex Gloves Should Be Avoided Because They Are More Permeable To Lindane. Lindane Shampoo Does Not Prevent Infestation Or Reinfestation And Should Not Be Used To Ward Off A Possible Infestation.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lindane LINDANE ZINC100024116

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