Your browser does not support JavaScript! REXALL LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [DOLGENCORP INC]
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REXALL LICE KILLING (piperonyl butoxide, pyrethrum extract) shampoo
[Dolgencorp Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

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

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

MAXIMUM STRENGTH

Lice Killing Shampoo

Lice Treatment

Works fast to kill lice and eggs

# nit combs included {Replace # with the number of combs in package}

Lice Killing Shampoo Carton Image 1

Lice Killing Shampoo Carton Image 1

Lice Killing Shampoo Carton Image 2

Lice Killing Shampoo Carton Image 2

REXALL LICE KILLING 
piperonyl butoxide, pyrethrum extract shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55910-705
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (PIPERONYL BUTOXIDE) PIPERONYL BUTOXIDE4 mL  in 100 mL
PYRETHRUM EXTRACT (PYRETHRUM EXTRACT) PYRETHRUM EXTRACT0.33 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
WATER 
XANTHAN GUM 
Product Characteristics
ColorYELLOW (cloudy to transparent, cream to straw) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-705-262 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358G11/19/2010
Labeler - Dolgencorp Inc (068331990)

Revised: 12/2011
 
Dolgencorp Inc

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