Label: PRONTO PLUS- pyrethrum extract and piperonyl butoxide shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 63736-210-12 - Packager: Insight Pharmaceuticals LLC
- 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.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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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
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Directions
Important: Read warnings before use.
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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
- 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
- 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
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Adults and children 2 years of age and over:
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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
- Inactive Ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL - Kit Carton
PRONTO®
PLUSComplete 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)
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- CONTAINS CHAMOMILE, ANISE, YLANG YLANG OIL & TEA TREE OIL
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- LEAVES NO CHEMICAL RESIDUE BEHIND
- 2
- LICE EGG REMOVER GEL AND COMB
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- 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 AidSHAMPOO 2 FL OZ (59 mL), GEL 2 FL OZ (59 mL), COMB, GLOVES, SPRAY 5 OZ (142 g)
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INGREDIENTS AND APPEARANCE
PRONTO PLUS LICE KILLING
pyrethrum extract and piperonyl butoxide shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrethrum Extract (UNII: ZUM06L90GV) (Pyrethrum Extract - UNII:ZUM06L90GV) Pyrethrum Extract 0.0033 mL in 1 mL Piperonyl Butoxide (UNII: LWK91TU9AH) (Piperonyl Butoxide - UNII:LWK91TU9AH) Piperonyl Butoxide 0.04 mL in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color WHITE (Clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-210-12 12 in 1 CASE 1 1 in 1 BOX 1 59 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358G 12/01/2010 Labeler - Insight Pharmaceuticals LLC (176792315)