Label: COMPLETE LICE TREATMENT KIT- piperonyl butoxide, pyrethrum extract kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 4, 2012

If you are a consumer or patient please visit this version.

  • Active ingredient

    Piperonyl butoxide 4%

    Pyrethrum extract (equivalent to 0.33% pyrethrins)

  • Purpose

    Lice treatment

  • Uses

    treats head, pubic (crab), and body lice

  • Warnings

    For external use only

    Do not use

    • near eyes
    • inside nose, mouth, or vagina
    • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

    Ask a doctor before use if you are

    allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

    When using this product

    • keep eyes tightly closed and protect eyes with a washcloth or towel
    • if product gets into eyes, flush with water right away
    • scalp itching or redness may occur

    Stop use and ask a doctor if

    • breathing difficulty occurs
    • eye irritation occurs
    • skin or scalp irritation continues or infection occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Shake well before using

    • Important: Read warnings before use

    Adults and children 2 years and over:

    Inspect

    • check each household member with a magnifying glass in bright light for lice/nits (eggs)
    • look for tiny nits near scalp, beginning at back of neck and behind ears
    • examine small sections of hair at a time
    • unlike dandruff which moves when touched, nits stick to the hair
    • if either lice or nits are found, treat with this product

    Treat

    • apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck.
    • allow product to remain for 10 minutes, but no longer
    • use warm water to form a lather, shampoo, then thoroughly rinse
    • for head lice, towel dry hair and comb out tangles

    Remove lice and their eggs (nits)

    • use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).
    • hair should remain slightly damp while removing nits
    • if hair dries during combing, dampen slightly with water
    • for head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours.
    • lift a 1- to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.
    • pin back each strand of hair after combing
    • clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.
    • after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
    • check daily for any lice/nits that you missed
    • a second treatment must be done in 7 to 10 days to kill any newly hatched lice
    • if infestation continues, see a doctor for other treatments
    • Children under 2 years: ask a doctor
  • Other information

    • store at 20°-25°C (68°-77°F)
    • keep carton for important product information
    • see package insert for additional information
  • Inactive ingredients

    benzyl alcohol, C13-C14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, water, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Consumer Information

    LICE KILLING SHAMPOO

    For the treatment of Head Lice, Pubic (Crab) Lice and Body Lice

    SHAKE WELL BEFORE USING

    DIRECTIONS: IMPORTANT: READ WARNINGS BEFORE USING. A SECOND TREATMENT MUST BE DONE IN 7-10 DAYS TO KILL ANY NEWLY HATCHED LICE

    Inspect • Check each household member with a magnifying glass in bright light for lice/nits (eggs) • Look for tiny nits near scalp, beginning at back of neck and behind ears • Examine small sections of hair at a time • Unlike dandruff which moves when touched, nits stick to the hair • If either lice or nits are found, treat with this product

    Treat • Apply thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck • Allow product to remain for 10 minutes but no longer • Use warm water to form a lather, shampoo, then thoroughly rinse • For head lice, towel dry hair and comb out tangles

    Remove Lice and their eggs (nits) • Use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove) • Hair should remain slightly damp while removing nits • If hair dries during combing, dampen slightly with water • For head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours • Lift a 1-2 inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp • Pin back each strand of hair after combing • Clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back • After combing, thoroughly recheck for lice/nits. Repeat combing if necessary • Check daily for any lice/nits that you missed• A second treatment must be done in 7 to 10 days to kill any newly hatched lice • If infestation continues, see a doctor for other treatments

    1. HEAD LICE: • Head lice lay small white eggs (nits) on the hair shaft close to the scalp • Nits are most easily found on the back of the neck or behind ears • Disinfect hats, hair ribbons, scarves, coats, towels and bed linens by machine washing in hot water (above 54° C (130° F)), then using hottest dryer cycle for at least 20 minutes • Items that cannot be washed (bedspreads, blankets, pillows, stuffed toys, etc.) should be dry-cleaned or sealed in a plastic bag for 4 weeks, then removed outdoors and shaken out very hard before using again • Items that cannot be washed, dry-cleaned, or stored may be sprayed with a product designed for this purpose • Soak all combs and brushes in hot water (above 54° C (130° F)) for at least 10 minutes • Vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people

    2. PUBIC (CRAB) LICE: • Pubic lice may be transmitted by sexual contact. • Sexual partners should be treated simultaneously to avoid reinfestation • Lice are very small and look like brown or grey dots on the skin • Pubic lice usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface • Pubic lice may be present on the short hairs of the groin, thighs, trunk and underarms, and occasionally on the beard and mustache • Disinfect underwear by machine washing in hot water (above 54° C (130° F)), then using hottest dryer cycle for at least 20 minutes

    3. BODY LICE: • Body lice and their eggs (nits) are generally found in the seams of clothing, particularly in the waistline and armpit area • Body lice feed on skin then return to clothing to lay their eggs • Disinfect clothing by machine washing in hot water (above 54° C (130° F)), then using hottest dryer cycle for at least 20 minutes • Do not seal clothing in a plastic bag because nits can remain dormant for up to 30 days

    Save this insert for future reference.

    Packaged by Perrigo, Allegan, MI 49010 USA

    CHAMPÚ PARA ELIMINAR PIOJOS

    Para el tratamiento de piojos de la cabeza, piojos del pubis (ladillas) y piojos del cuerpo

    AGITE MUY BIEN EL PRODUCTO ANTES DE USARLO

    INSTRUCCIONES: ES IMPORTANTE QUE LEA LAS ADVERTENCIAS ANTES DE USAR EL PRODUCTO. DEBE REALIZAR UN SEGUNDO TRATAMIENTO 7 A 10 DÍAS DESPUÉS PARA ELIMINAR LA REPRODUCCIÓN DE NUEVOS PIOJOS

    Inspección • Revise a cada miembro de su familia con una lupa, a la luz del día, para encontrar piojos o huevecillos (liendres) • Busque las diminutas liendres cerca del cuero cabelludo, empezando por la nuca y detrás de las orejas • Examine pequeñas secciones de cabello una por una • Las liendres se adhieren al cuero cabelludo, lo cual las diferencia de la caspa, que se suelta al contacto • Si encuentra piojos o liendres, trátelos con este producto

    Tratamiento • Aplique sobre todo el cabello seco u otras áreas afectadas. Para piojos de la cabeza, primero aplique detrás de las orejas y en la nuca • Deje el producto aplicado durante 10 minutos, sin exceder el tiempo sugerido • Use agua tibia para formar espuma, lave con champú y luego enjuague muy bien • para piojos de la cabeza, seque el cabello con una toalla y desenrede con un peine

    Remueva los piojos y sus liendres (huevecillos) • Use un peine fino o un peine especial para piojos/liendres. Remueva todas las liendres restantes a mano (use guantes desechables) • El cabello debe permanecer apenas húmedo mientras remueve las liendres • Si el cabello se seca mientras lo peina, humedézcalo apenas con agua • Para piojos de la cabeza, divida el cabello en secciones. Revise una sección por vez, empezando por la parte de arriba de la cabeza. Si tiene el cabello largo, esto le puede llevar de 1 a 2 horas • Levante mechones de 2.5 a 5 cm (1 a 2 pulgadas) de anchura. Ponga el peine lo más cerca posible del cuero cabelludo y peine con movimientos firmes y uniformes • Sujete cada mechón de cabello después de peinarlo • Limpie el peine con frecuencia. Quite las liendres con un pañuelo de papel y arrójelas en una bolsa plástica. Cierre la bolsa y deséchela para evitar que los piojos vuelvan a aparecer • Después de peinar, vuelva a revisar exhaustivamente para ver si encuentra piojos o liendres. Si fuera necesario, repita el procedimiento • Revise a diario para ver si aparece algún piojo o liendre• Debe realizar un segundo tratamiento después de 7 a 10 días para matar piojos recién nacidos • Si la infestación continúa, debe consultar a su médico acerca de otros tratamientos

    PACKAGE LEAFLET – SPANISH CONTINUED

    1. PIOJOS DE LA CABEZA: • Los piojos de la cabeza ponen pequeños huevecillos blancos (liendres) en los mechones de cabello, cerca del cuero cabelludo • Las liendres son fáciles de encontrar en la nuca o detrás de las orejas • Desinfecte sombreros, moños, bufandas, abrigos, toallas y sábanas; lávelos en la lavadora con agua caliente (a más de 54°C (130°F)); después use el ciclo de secado más caliente al menos durante 20 minutos • Los artículos que no se puedan lavar (cubrecamas, frazadas, almohadas, juguetes de peluche, etc.) se deben limpiar en seco o guardar en bolsas plásticas por cuatro semanas, después se los debe sacar a la intemperie y sacudir enérgicamente antes de ser usados otra vez • Los artículos que no se puedan lavar, limpiar en seco o guardar se deben rociar con productos designados para este fin • Sumerja todos los peines y cepillos en agua caliente (a más de 54°C (130°F)) al menos durante 10 minutos • Aspire las alfombras, colchones, muebles tapizados y asientos del automóvil que puedan haber sido usados por las personas afectadas

    2. PIOJOS DEL PUBIS (LADILLAS): • Los piojos del pubis se pueden transmitir por contacto sexual • Los compañeros sexuales se deben recibir tratamiento simultáneo para evitar la reinfestación • Los piojos son muy pequeños y parecen puntos de color café o gris en la piel • Los piojos del pubis producen picazón muy intensa y ponen huevecillos muy pequeños (liendres) en los mechones de pelo, generalmente cerca de la superficie de la piel • Los piojos del pubis pueden estar presentes en los pelos cortos de la ingle, muslos, tronco, axilas y, ocasionalmente, en la barba y el bigote. Lave la ropa interior en la lavadora con agua caliente (a más de 54°C (130°F)) para desinfectarla y después use el ciclo de secado más caliente durante más de 20 minutos

    3. PIOJOS DEL CUERPO: • Los piojos del cuerpo y sus huevos (liendres) generalmente se encuentran en las costuras de la ropa, particularmente en el elástico de la cintura o en la zona de la axila • Los piojos del cuerpo se alimentan de la piel y luego regresan a la ropa para depositar sus huevos • Lave la ropa en la lavadora con agua caliente (a más de 54°C (130°F)) para desinfectarla y después use el ciclo más caliente de la secadora, por lo menos durante 20 minutos • No guarde la ropa en bolsas de plástico, pues las liendres permanecen en estado latente por más de 30 días

    Guarde estas instrucciones para consulta futura.

    Empacado por Perrigo, Allegan, MI 49010 EE. UU.

  • Principal Display Panel

    STOP LICE

    COMPLETE LICE TREATMENT KIT

    1-2-3 LICE CONTROL SYSTEM

    STEP 1 LICE KILLING SHAMPOO

    Lice Treatment

    Works fast to kill lice and eggs

    STEP 2 EGG & NIT COMBING GEL

    Lice comb removes nits and eggs

    Makes combing faster and easier

    STEP 3 BEDDING SPRAY LICE TREATMENT

    For bedding and furniture

    Kills lice and their eggs on mattresses, furniture, car interiors and other non-washable items

    Compare to RID® Lice Killing Shampoo active ingredients

    KEEP OUT OF REACH OF CHILDREN

    CAUTION

    See back and side panels for additional information.

    Complete Lice Treatment Kit Carton Image 1

    Complete Lice Treatment Kit Carton Image 1

    Complete Lice Treatment Kit Carton Image 2

    Complete Lice Treatment Kit Carton Image 2

  • INGREDIENTS AND APPEARANCE
    COMPLETE LICE TREATMENT KIT 
    piperonyl butoxide, pyrethrum extract kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0173
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0173-241 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 57 g
    Part 1 of 2
    LICE KILLING 
    piperonyl butoxide, pyrethrum extract shampoo
    Product Information
    Item Code (Source)NDC:0363-0866
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE4 mL  in 100 mL
    PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.33 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    Product Characteristics
    ColorYELLOW (cloudy to transparent, cream to straw) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0866-261 in 1 CARTON
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G09/10/2007
    Part 2 of 2
    EGG AND NIT 
    combing aid gel
    Product Information
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    157 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other10/29/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G10/29/2007
    Labeler - Walgreen Company (008965063)