FDA Label for Pronto Plus Lice Killing
View Indications, Usage & Precautions
Pronto Plus Lice Killing Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Lice Killing Shampoo with Extracts
Drug Facts
- visit our website at www.insightpharma.com
Distributed by:
INSIGHT Pharmaceuticals Corp.
1170 Wheeler Way
Langhorne, PA 19047-1749
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
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.
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
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 BEHIND2 LICE EGG REMOVER GEL AND COMB— GEL MAKES LICE NIT (EGG) REMOVAL EASIER THAN
LICE KILLING SHAMPOO ALONE— INCLUDES NIT REMOVAL COMB3 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)
* Please review the disclaimer below.