FDA Label for Rexall Lice Killing
View Indications, Usage & Precautions
Rexall Lice Killing Product Label
The following document was submitted to the FDA by the labeler of this product Dolgencorp Inc. 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.
Active Ingredient
Piperonyl butoxide 4%
Pyrethrum extract (equivalent to 0.33% pyrethrins)
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 into 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
Shake well before using
• Important: Read warnings before use• check each household member with a magnifying glass in bright light for lice/nits (eggs)• 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• 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 the 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/nits. Repeat combing if necessary.• check daily for any lice/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: ask a doctor
Adults and children 2 years and over:
Inspect
Treat
Remove lice and their eggs (nits)
Other Information
• store at 20°-25°C (68°-77°F)• keep carton for important product information• see package insert for additional information
Inactive Ingredients
benzyl alcohol, C13-C14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, water, xanthan gum
Consumer Information
Steps to Success
with 1-2-3 Lice Control System
Complete lice control for your family and home
Step 1: Treat
Lice Killing Shampoo
See Usage Guidelines to estimate how much product you will need.
Inspect
• Check each household member with a magnifying glass in bright light for lice/nits (eggs).• 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.
• Use towels to protect child's eyes from treatment and prevent clothes from getting wet.
• Apply Lice Killing Shampoo thoroughly to DRYHAIR or other affected area.
• Wetting the hair dilutes the treatment making it less effective.
• Also, lice can hold their breath when immersed in water making it difficult for the active ingredient to penetrate the lice.
• A fine-toothed comb or the special lice/nit removing comb (included) must be used to remove lice, eggs, and nits from hair.
• Before starting have on hand:
- Extra towels- Bobby pins or hair clips- Facial tissues or paper towels- Regular comb for parting and detangling hair- Throw-away gloves• Find a distraction for your child (e.g. books, TV, game).• Comb out damp hair with a regular wide-tooth comb to take out snarls and tangles.• Use Home Lice, Bedbug & Dust Mite Spray to kill lice and their eggs on mattresses, furniture, car interiors and other non-washable items. A regular disinfectant spray will not kill lice and their eggs.
• After spraying the infested area, vacuum rugs and carpets. Dispose of the vacuum cleaner bags after use.
• Wash all clothes, towels, washable hats, scarves, coats and bed linens in hot water. Dry in high heat for at least 20 minutes.
• Dry clean non-washables.
• Personal combs and brushes may be disinfected by soaking in hot water (above 54°C (130°F)) for at least 10 minutes.
• Place stuffed toys in plastic bags and seal them for 4 weeks.
- Home and auto upholstery- Mattresses, pillows, pillowcases- Bed linen- Towels- Stuffed animals, toys- Headphones- Hats- - Headbands- Bike/sports helmets- Coats, scarves, earmuffs, gloves- Play mats- Clothing- Barrettes/hair ornaments- Hair rollers- Combs and brushes- - Baseball caps• 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.
• 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.
• May be transmitted by sexual contact. Sexual partners should be treated simultaneously to avoid reinfestation.
• Lice are very small and look like brown or grey dots on skin.
• Usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface.
• May be present on the short hairs of groin, thighs, trunk, and underarms, and occasionally on the beard and mustache.
• Disinfect underwear by machine washing in hot water (above 54°C (130°F)), then using hottest dryer cycle for at least 20 minutes.
• Body lice and their eggs (nits) are generally found in the seams of clothing particularly in waistline and armpit area.
• Body lice feed on skin then return to clothing to lay their eggs.
• Disinfect clothing by machine washing in hot water (above 54°C (130°F)), then using hottest dryer cycle for at least 20 minutes.
• Do not seal clothing in a plastic bag because nits can remain dormant for up to 30 days.
• near eyes• inside nose, mouth, or vagina• on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.• allergic to ragweed. May cause breathing difficulty or an asthmatic attack.• 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• breathing difficulty occurs• eye irritation occurs• skin or scalp irritation continues or infection occurs• Important: Read warnings before use• store at 20-25°C (68-77°F)• Take off contaminated clothing.• Rinse skin immediately with plenty of water for 15-20 minutes.• Call a poison control center or doctor for treatment advice.• Hold eye open and rinse slowly and gently with water for 15-20 minutes.• Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.• Call a poison control center or doctor for treatment advice.• Do not allow adults, children, or pets to enter until vapors, mists and aerosols have dispersed, and the treated area has been thoroughly ventilated.• Do not allow adults, children, or pets to enter the treated area until sprays have dried.• In the home, all food processing surfaces and utensils should be covered during treatment or thoroughly washed before use. Exposed food should be covered or removed.• Remove pets, birds and cover any water inhabited by fish (such as aquariums and ornamental fish ponds) before application. Turnoff aquarium filtering systems before spraying and wait approximately 15 minutes after application before turning the filter back on.• This product is not for use on humans. If lice infestations should occur on humans, use a product labeled for use on humans.• Application is prohibited directly into sewers or drains, or to any area like a gutter where drainage to sewers, storm drains, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application.• Not for broadcast use on indoor residential surfaces.
NOTE:
• For head lice, thoroughly massage shampoo into scalp, behind the ears and to the back of the neck. Lice can crawl up and down the shaft of the hair very quickly so it is important to apply the treatment from the roots to the ends of the hair.
• Allow product to remain on the hair (or other affected area) for 10 minutes, but no longer.
• Add warm water and massage to form a lather.
• Shampoo, then rinse thoroughly.
For head lice, towel dry hair and comb out tangles.
• Proceed to Step 2.
• A second treatment must be done in 7 to 10 days to kill any newly hatched lice.
Step 2: Remove
Lice & Egg Comb-Out Gel
This product should be used AFTER Lice Killing Shampoo (Step 1). Combing out eggs & nits* is an essential step to complete lice control.
See Usage Guidelines to estimate how much product you will need.
NOTE:
• Apply Lice & Egg Comb-Out Gel to one section of hair. (Do not apply to entire head at once, since gel dries quickly.)
• Massage thoroughly until all strands of hair in this section are covered with the gel.
• When combing, use the fine-toothed lice/nit comb provided and make sure the teeth are facing you.
• 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 small strand of hair (about 1-2" wide) from the section with the gel.
• Begin combing in a "scooping" motion. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp, from the roots to the ends of the hair (newly-laid eggs are found near the roots of the hair so it is important to get the teeth very close to the scalp). Make sure the teeth are deeply embedded into the strands as you comb through.
• Always comb away from the head.
• Wipe eggs and nits from the teeth of the comb often with a tissue or paper towel.
• Remove any remaining nits by hand (using a throw-away glove).
• Pin back the strand you just finished combing with a bobby pin or hair clip.
• Lift up another 1-2 inch wide strand with gel and repeat the combing procedure.
• When one section with gel has been combed and pinned, apply Lice & Egg Comb-Out Gel to another section of hair. Continue to comb hair 1-2 inches at a time until entire head has been combed and pinned.
• Keep the hair damp during combing. If hair dries during combing, dampen slightly with water, and re-apply Lice & Egg Comb-Out Gel as needed.
• After you have combed and pinned the entire head, remove all bobby pins or hair clips and thoroughly recheck for lice/nits. Repeat combing if necessary. Rinse hair thoroughly with warm water. If desired, you may also wash with regular shampoo.
• Discard all the used tissues or cloths into a sealed plastic bag and dispose of immediately to prevent lice from coming back.
* Nits are empty eggshells left behind when lice hatch from eggs.
Step 3: Control
Home Lice, Bedbug & Dust Mite Spray
Checklist
Daily Checking
TO PREVENT REINFESTATION:
• Carefully inspect infested family member daily for at least 2 weeks. If you see eggs or nits, repeat Step 2.
• Check other family members for Head Lice. If anyone in the family is infested, follow Step 1 and Step 2. Repeat Step 3 with any articles or items with which they have come into contact.
Second Application
Repeat the same procedures within 7-10 days for
Step 1: Treat and Step 2: Remove
There may be some eggs that were not combed out after the first treatment. These eggs will hatch and need to be killed with the second treatment.
If infestation continues, see a doctor for other treatments.
Did You Know?
Head Lice
Pubic (Crab) Lice
Body Lice
Save this insert for future reference
Distributed By
Perrigo®
Allegan, MI 49010
:1010000J1
Keep carton for important product information.
Lice Killing Shampoo
Drug Facts
Active ingredients
Piperonyl butoxide 4%
Pyrethrum extract
(equivalent to 0.33% pyrethrins)
Purpose
Lice treatment
Uses
treats head, pubic (crab), and body lice
Warnings
For external use only
Do not use
Ask a doctor before use if you are
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
Other information
Inactive ingredients
benzyl alcohol, C13-C14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, purified water, xanthan gum
Questions {or comments}?
Lice & Egg Comb-Out Gel
Product Information
Use
to make egg and nit removal from the hair faster and easier
Warnings
For external use only. Keep out of reach of children.
Ingredients
purified water, glycerin, hydroxyethylcellulose, PG-hydroxyethylcellulose cocodimonium chloride, polysorbate 20, DMDM hydantoin, fragrance, iodopropynyl butylcarbamate
Store at 20-25°C (68-77°F)
Home Lice, Bedbug & Dust Mite Spray
Not for use on humans
ACTIVE INGREDIENT:
†Permethrin | 0.50% |
††OTHER INGREDIENTS: | 99.50% |
100.00% |
†Cis/trans ratio: Max. 55% (+/-) cis and Min. 45% (+/-) trans.
††Contains petroleum distillate
FIRST AID
If on skin or clothing:
If in eyes:
HOT LINE NUMBER
Have the product container or label with you when calling a poison control center or doctor, or going for treatment. For additional information on this product (including health concerns, medical emergencies or pesticide incidents), you may call 1-800-222-1222.
NOTE TO PHYSICIAN
Contains petroleum distillate – vomiting may cause aspiration pneumonia.
PRECAUTIONARY STATEMENTS
Hazards To Humans & Domestic Animals
CAUTION: Harmful if absorbed through skin. Causes moderate eye irritation. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco or the toilet. Remove and wash contaminated clothing before reuse.
PHYSICAL OR CHEMICAL HAZARDS
Contents under pressure. Do not use or store near heat or open flame. Do not puncture or incinerate container. Exposure to temperatures above 130°F (54°C) may cause bursting.
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent with its labeling.
Use Restrictions:
SHAKE WELL BEFORE USING
Remove protective cap. Hold container upright with nozzle away from you. Depress valve and spray from a distance of 8-10 inches (12 to 15 inches for baseboards, moldings and floors). Test product on an inconspicuous area before applying to check for possible staining or discoloration. Inspect again after drying. Spray to the point of dampness but not run-off. Over application may cause damage. Will not stain surfaces or fabrics where water alone causes no damage.
To kill Lice and Louse eggs: Clean home. Use this product for non-washable items. Washables should be washed in hot water and dried in high heat. Spray in an inconspicuous area to test for possible staining or discoloration. Inspect again after drying, then proceed to spray entire area to be treated. Hold container upright with nozzle away from you. Depress valve and spray from a distance of 8 to 10 inches. Spray each square foot for three seconds. Spray to the point of dampness but not run-off. Allow all sprayed articles to dry thoroughly before use. If lice infestation occurs on humans, use a product labeled for use on humans. Spray only those articles and parts of bedding including mattresses and furniture that cannot be either laundered or dry-cleaned. Do not use on sheets or pillowcases.
Bedbugs: Spray mattresses, particularly around tufts and seams. Take beds apart and spray into all joints. Treat baseboards, moldings and floors. Spray to the point of dampness but not run-off. After mattress is dry, cover with mattress cover and sheet. Do not use mattress without cover. Retreat if infestation occurs, but not more than once every two weeks.
To kill House Dust Mites (Dermatophagoides spp.) a multi-use lice spray controls house dust mites that may cause asthma, hay fever, rhinitis, watery eyes and sneezing. One treatment lasts for up to 8 weeks. On Upholstered Furniture – test fabric in an inconspicuous area to insure dyes will not bleed. Spray all fabric surfaces until damp. Do not use on delicate fabrics. Allow furniture to dry thoroughly before using. On Carpets – Spray over entire carpet until damp. Hold nozzle approximately 12 to 18 inches from the carpet surface and spray in a sweeping motion. Use an overlapping pattern to insure total coverage. After application, brush the surface of the carpet with a broom or brush to insure deep penetration. Allow carpet to dry thoroughly before reentering the treated area. Drying time can be accelerated by using a fan. On Mattresses – Spray the top, bottom and sides of mattresses until damp, paying particular attention to tufts and seams. Allow to dry thoroughly before using. After mattress is dry, cover with mattress cover and sheet. Do not use mattress without cover. Vacuum entire area once dry. Since vacuuming stirs dust up in the air those with allergies should have another person vacuum or should wear a dust mask and use vacuum with a high efficiency particulate (HEPA) filter.
STORAGE AND DISPOSAL
Do not contaminate water, food or feed by storage or disposal.
Storage: Store in a cool, dry area away from children and pets and away from heat, sparks and open flame. Do not transport or store below 32°F (0°C).
Pesticide Disposal and Container Handling: Do not puncture or incinerate.
If empty: Place in trash or offer for recycling if available.
If partly filled: Call your local solid waste agency or 1-800-CLEANUP (253-2687) for disposal instructions.
To the extent consistent with applicable law, purchaser assumes all responsibility for safety and use not in accordance with directions.
See carton for EPA numbers.
Principal Display Panel
MAXIMUM STRENGTH
Lice Killing Shampoo
Lice Treatment
Works fast to kill lice and eggs
2 nit combs included
2-4 FL OZ BOTTLES
4 + 4 = 8 FL OZ (236 mL)
* Please review the disclaimer below.