PRONTO PLUS  LICE KILLING- pyrethrum extract and piperonyl butoxide shampoo 
Insight Pharmaceuticals LLC

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.

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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.

Other Information

HEAD LICE: lay small white eggs (nits) on hair shaft close to scalp

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

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)

Principal Display Panel - Kit Carton
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)

Revised: 1/2011
Document Id: 2d148ca6-9415-44c3-a791-d5d3ce13ea7c
Set id: 3cdec6f3-4da6-467f-96c3-c8941ff46b56
Version: 1
Effective Time: 20110120
 
Insight Pharmaceuticals LLC