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Pronto Plus Lice Killing

Medically reviewed on January 22, 2018

Dosage form: shampoo
Ingredients: Pyrethrum Extract 0.0033mL in 1mL, Piperonyl Butoxide 0.04mL in 1mL
Labeler: Insight Pharmaceuticals LLC
NDC Code: 63736-210

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.

PRONTO®
PLUS

Lice Killing Shampoo with Extracts

Drug Facts

Active ingredients

Pyrethrum extract (pyrethrins 0.33%) with piperonyl butoxide 4%

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.

Directions

Important: Read warnings before use.

  • Adults and children 2 years of age and over:
    Inspect
    • check each household member with a magnifying glass in bright light for lice and nits
    • 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 bottle well
    • 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 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 and nits. Repeat combing if necessary.
    • check daily for any lice and 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 of age: ask a doctor

Other Information

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
  • allow all sprayed articles to dry thoroughly before use
  • 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

Keep carton for full drug facts and warnings. Read all warnings and directions before use.

  • visit our website at www.insightpharma.com

Inactive Ingredients

cananga odorata flower oil, chamomilla recutita (matricaria) flower extract, fragrance, melaleuca alternifolia (tea tree) leaf oil, PEG-45 palm kernel glycerides, pimpinella anisum (anise) fruit extract, propylene glycol, water, sodium laureth sulfate.

Questions?

call 1-888-542-3546

Distributed by:
INSIGHT Pharmaceuticals Corp.
1170 Wheeler Way
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - Kit Carton

PRONTO®
PLUS

Complete Lice Removal System

3-STEP LICE ELIMINATION KIT

1
LICE KILLING SHAMPOO WITH EXTRACTS
Pyrethrum extract (pyrethrins 0.33%) with piperonyl butoxide 4% (Lice treatment)
MAXIMUM STRENGTH LICE KILLING INGREDIENT TO KILL LICE & NITS (their eggs)
CONTAINS CHAMOMILE, ANISE, YLANG YLANG OIL & TEA TREE OIL
LEAVES NO CHEMICAL RESIDUE BEHIND
2
LICE EGG REMOVER GEL AND COMB
GEL MAKES LICE NIT (EGG) REMOVAL EASIER THAN
LICE KILLING SHAMPOO ALONE
INCLUDES NIT REMOVAL COMB
3
PRONTO® PLUS HOUSEHOLD SPRAY KILLS
LICE, TICKS, FLEAS, DUST MITES & BEDBUGS
Kills Adult Lice & Nymphs as They Hatch on Bedding, Garments, Furniture and Other Inanimate Objects

CAUTION: KEEP OUT OF REACH OF CHILDREN
See Back/Side Panel For Additional Precautions And First Aid

SHAMPOO 2 FL OZ (59 mL), GEL 2 FL OZ (59 mL), COMB, GLOVES, SPRAY 5 OZ (142 g)

PRONTO PLUS   LICE KILLING
pyrethrum extract and piperonyl butoxide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-210
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrethrum Extract (Pyrethrum Extract) Pyrethrum Extract0.0033 mL  in 1 mL
Piperonyl Butoxide (Piperonyl Butoxide) Piperonyl Butoxide0.04 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Cananga Oil 
Chamomile 
Tea Tree Oil 
Pimpinella Anisum 
Propylene Glycol 
Sodium Laureth Sulfate 
Product Characteristics
ColorWHITE (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63736-210-1212 BOX (BOX) in 1 CASE
11 BOTTLE (BOTTLE) in 1 BOX
159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358G12/01/2010
Labeler - Insight Pharmaceuticals LLC (176792315)

 
Insight Pharmaceuticals LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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