Label: PRONTO PLUS- pyrethrum extract and piperonyl butoxide shampoo

  • 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 January 20, 2011

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

  • SPL UNCLASSIFIED SECTION

    Lice Killing Shampoo with Extracts

  • SPL UNCLASSIFIED SECTION

    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.

  • SPL UNCLASSIFIED SECTION

    • 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

  • SPL UNCLASSIFIED SECTION

    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)

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    PRONTO PLUS   LICE KILLING
    pyrethrum extract and piperonyl butoxide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrethrum Extract (UNII: ZUM06L90GV) (Pyrethrum Extract - UNII:ZUM06L90GV) Pyrethrum Extract0.0033 mL  in 1 mL
    Piperonyl Butoxide (UNII: LWK91TU9AH) (Piperonyl Butoxide - UNII:LWK91TU9AH) Piperonyl Butoxide0.04 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cananga Oil (UNII: 8YOY78GNNX)  
    Chamomile (UNII: FGL3685T2X)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Pimpinella Anisum (UNII: HO63CL229O)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Product Characteristics
    ColorWHITE (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-210-1212 in 1 CASE
    11 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)