Label: EQUATE LICE KILLING- piperonyl butoxide, pyrethrum extract shampoo

  • NDC Code(s): 49035-866-30, 49035-866-34
  • Packager: Wal-Mart Stores Inc
  • 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 6, 2018

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 (1-800-222-1222).

  • Directions

    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

    shake well before using
    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)
    avoid excessive heat
    keep carton for important product information
    see Consumer Information 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?

    1-888-287-1915

    Consumer Information

    Steps to Success with 1-2-3 Lice Control System

    Complete lice control for your family and home.

    Step 1: Treat

    Lice Killing Shampoo

    See Usage Guidelines to estimate how much product you will need.

    NOTE:

    Shake well before using.
    Use towels to protect child's eyes from treatment and prevent clothes from getting wet.
    Apply Lice Killing Shampoo thoroughly to DRY HAIR or other affected area.
    Wetting the hair dilutes the treatment making it less effective.
    Also, lice can hold their breath when immersed in water making it difficult for the active ingredient to penetrate the lice.
    Image 1
    For head lice, thoroughly massage shampoo into scalp, behind the ears and to the back of the neck. Lice can crawl up and down the shaft of the hair very quickly so it is important to apply the treatment from the roots to the ends of the hair.
    Image 2
    Allow product to remain on the hair (or other affected area) for 10 minutes, but no longer.
    Image 3
    Add warm water and massage to form a lather.
    Rinse thoroughly.
    Image 4
    For head lice, towel dry hair and comb out tangles.
    Proceed to Step 2.
    A second treatment must be done in 7 to 10 days to kill any newly-hatched lice.
    usage guidelines image

    Step 2: Remove

    Lice/Nit Comb

    Combing must be done AFTER use of Lice Killing Shampoo (Step 1). Combing out eggs & nits* is an essential step to complete lice control.

    NOTE:

    A fine-toothed comb or the special lice/nit removing comb (included) must be used to remove lice, eggs, and nits from hair.
    Before starting have on hand
    -
    extra towels
    -
    bobby pins or hair clips
    -
    facial tissues or paper towels
    -
    regular comb for parting and detangling hair
    -
    detangler/conditioner to make combing easier
    Find a distraction for your child (e.g. books, TV, game).
    Image 5
    Apply detangler/conditioner and comb out damp hair with a regular wide-tooth comb to take out snarls and tangles.
    Hold the Lice/Nit comb with the teeth facing you.
    Image 6
    Working one section at a time, lift a 1- to 2- inch wide strand of hair.
    Place comb as a close to the scalp as possible and comb with a firm, even motion away from scalp, from the roots to the end of the hair (newly-laid eggs are found near the roots of the hair so it is important to get the teeth very close to the scalp). Make sure the teeth are deeply embedded into the strands as you comb through.
    Always comb away from the head.
    Wipe eggs and nits from the teeth of the comb with a tissue or paper towel.
    Image 7
    Pin back the 1- to 2-inch wide strand you just finished combing with a bobby pin or hair clip.
    Lift up another 1- to 2-inch wide strand and repeat the combing procedure.
    When one section has been combed and pinned, repeat the process for another section of hair. Continue to comb hair 1- to 2-inches at a time until entire head has been combed and pinned.
    Image 8
    Keep the hair damp during combing and re-apply detangler/conditioner as needed.
    After you have combed and pinned the entire head, remove all bobby pins or hair clips and rinse hair thoroughly with warm water. If desired, you may also wash with regular shampoo.
    Discard all the used tissues or paper towels into a bag, seal and dispose to prevent lice from coming back.

    * Nits are empty eggshells left behind when lice hatch from eggs.

    Step 3: Control

    Home Lice, Bedbug & Dust Mite Spray

    Use Home Lice, Bedbug & Dust Mite Spray to kill lice and their eggs on mattresses, furniture, car interiors and other non-washable items. A regular disinfectant spray will not kill lice and their eggs.
    After spraying the infested area, vacuum rugs and carpets. Dispose of the vacuum cleaner bags after use.
    Wash all clothes, towels, washable hats, scarves, coats and bed linens in hot water. Dry in high heat for at least 20 minutes.
    Dry clean non-washables.
    Personal combs and brushes may be disinfected by soaking in hot water [above 54°C (130°F)] for at least 10 minutes.
    Place stuffed toys in plastic bags and seal them for 4 weeks.

    Checklist

    -
    Home and auto upholstery
    -
    Bike/sport helmets
    -
    Mattresses, pillows, pillowcases
    -
    Coats, scarves, earmuffs, gloves
    -
    Bed linen
    -
    Play mats
    -
    Towels
    -
    Clothing
    -
    Stuffed animals, toys
    -
    Barrettes/hair ornaments
    -
    Headphones
    -
    Hair rollers
    -
    Hats
    -
    Combs and brushes
    -
    Headbands
    -
    Baseball caps

    Daily Checking

    TO PREVENT REINFESTATION:

    Carefully inspect infested family member daily for at least 2 weeks. If you see eggs or nits, repeat Step 2.
    Check other family members for Head Lice. If anyone in the family is infested, follow Step 1 and Step 2. Repeat Step 3 with any articles or items with which they have come into contact.

    Second Application

    Repeat the same procedures within 7-10 days for

    Step 1: Treat and Step 2: Remove

    There may be some eggs that were not combed out after the first treatment. These eggs will hatch and need to be killed with the second treatment.

    Did You Know?

    Head Lice

    Lay small white eggs (nits) on hair shaft close to scalp.
    Nits are most easily found on back of 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, such as a Home Lice, Bedbug & Dust Mite Spray.
    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.

    Pubic (Crab) 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 skin.
    Usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface.
    May be present on the short hairs of 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.

    Body Lice

    Body Lice and their eggs (nits) are generally found in the seams of clothing particularly in 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.

    Distributed By

    Perrigo ®

    Allegan, MI 49010

    : 8660000J5

    Lice Killing Shampoo

    Drug Facts

    Active ingredients

    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 in 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 (1-800-222-1222).

    Directions

    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

    shake well before using
    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 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). Avoid excessive heat.

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

    Questions?

    800-719-9260

  • Principal Display Panel

    Compare to RID® Lice Killing Shampoo Active Ingredients

    Maximum Strength

    Lice Killing Shampoo

    Lice Treatment

    1 Clean 1-2-3 Lice Elimination System

    Works fast to kill lice and eggs

    Will not leave a chemical residue

    Helps children return to school nit free

    One nit comb included

    6 FL OZ (177mL)

    866-2e-lice-killing-shampoo.jpg
  • INGREDIENTS AND APPEARANCE
    EQUATE LICE KILLING 
    piperonyl butoxide, pyrethrum extract shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-866
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE4 g  in 100 mL
    PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.33 g  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:49035-866-301 in 1 CARTON07/09/2007
    1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49035-866-341 in 1 CARTON07/12/2007
    2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G07/08/2007
    Labeler - Wal-Mart Stores Inc (051957769)