smart sense lice killing

Dosage form: shampoo
Ingredients: PIPERONYL BUTOXIDE 4g in 100mL, PYRETHRUM EXTRACT 0.33g in 100mL
Labeler: Kmart Corporation
NDC Code: 49738-866

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.

Kmart Corporation 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
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. (1-800-222-1222)

Directions

Shake well before using

Important: Read warnings before use

Adults and children 2 years and over:

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

Treat

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 their eggs (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 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

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

Questions or comments?

1-800-719-9260

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 below 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

NOTE:

• Use towels to protect child's eyes from treatment and prevent clothes from getting wet.

• Apply Lice Killing Shampoo thoroughly to DRY HAIR 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.

• 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.

• 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

Egg & Nit Combing 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 below to estimate how much product you will need.

NOTE:

• A fine-toothed comb or a 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.

• Apply Egg & Nit Combing 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" thick) from the section with the gel.

• Begin combing in a "scooping" motion: gently push the teeth as close to the scalp as possible and drag comb firmly and evenly from the scalp 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).

• Discard all the used tissues or cloths into a sealed plastic bag and dispose of immediately to prevent lice from coming back.

• Pin back the strand you just finished combing with a bobby pin or hair clip.

• Lift up another 1-2 inch strand with gel and repeat the combing procedure.

• When one section with gel has been combed and pinned, apply Egg & Nit Combing 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 Egg & Nit Combing 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.

* Nits are empty eggshells left behind when lice hatch from eggs.

Step 3: Control

Lice Control Spray

Use Lice Control Spray to kill lice and their eggs on mattresses, furniture, car interiors and other non-washable items.

• Use Lice Control 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 130°F) for at least 10 minutes.

• Place stuffed toys in plastic bags and seal them for 4 weeks.

• Disinfectant Checklist

- 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

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

• 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

Pubic (Crab) Lice

• 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

• 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

Save this insert for future reference

Keep carton for important product information.

Lice Killing Shampoo

Drug Facts

Active ingredients Purpose

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 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. (1-800-222-1222)

Directions

Shake well before using

Important: Read warnings before use

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

benzyl alcohol, C13-C14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, purified water, xanthan gum

Questions or comments?

1-800-719-9260

Egg & Nit Combing Gel

Product Facts

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)

Lice Control Spray

Product Facts

ACTIVE INGREDIENT:

*Permethrin.................................................................................................................0.50%

**OTHER INGREDIENTS:....................................................................................99.50%

100.00%

*Cis/trans ratio: Min. 35% (+/-) cis and Max. 65% (+/-) trans.

**Contains Petroleum distillate

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS

CAUTION: Harmful if swallowed or absorbed through skin. Avoid inhalation of spray mist. Causes eye irritation. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling. Avoid contamination of feed and foodstuffs.

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.

FIRST AID

Call a Poison Control Center or doctor immediately for treatment advice. Have product container or label with you when calling a Poison Control Center or doctor or going for treatment.

If swallowed:

Immediately call a Poison Control Center or doctor.
Do not induce vomiting unless told to do so by a Poison Control Center or doctor.
Do not give any liquid to the person.
Do not give anything by mouth to an unconscious person.

If in eyes:

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.

If inhaled:

Move person to fresh air.
If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably by mouth-to-mouth, if possible.

If on skin or clothing:

Take off contaminated clothing.
Rinse skin immediately with plenty of water for 15-20 minutes.

NOTE TO PHYSICIAN

Contains petroleum distillate – vomiting may cause aspiration pneumonia.

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Remove pets and birds and cover fish aquaria before space spraying or surface applications.

This product is not for use on humans. If lice infestation occurs on humans, use a product labeled for use on humans. Vacate room after treatment and ventilate before reoccupying. Do not allow children or pets to contact treated areas until surfaces are dry.

SHAKE WELL BEFORE USING

Remove protective cap. Hold container upright and spray from a distance of 8-10 inches. Individuals with asthma or severe allergies should consult their doctor before using this product and have someone else apply this product.

To kill lice and louse eggs: 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. Spray only those articles and parts of bedding including mattresses and furniture, that cannot be either laundered or dry-cleaned. Do not use on pillowcases, sheets or clothing. Allow all sprayed articles to dry thoroughly before each use.

STORAGE AND 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).

Container disposal: 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 for disposal instructions. Never place unused product down any indoor or outdoor drain.

NOTICE: Purchaser assumes all responsibility for safety and use not in accordance with directions.

See carton for EPA numbers.

: 0N800 00 J2

Principal Display Panel

Compare to the active ingredients of RID® Lice Killing Shampoo

LICE TREATMENT

Maximum Strength

Lice Killing Shampoo

Piperonyl Butoxide 4%

Pyrethrum Extract (equivalent to 0.33% pyrethrins)

Works Fast to Kill Lice and Eggs

Will Not Leave a Chemical Residue

For Treatment of:

Head Lice, Crab Lice and Body Lice

2 Nit Removal Combs Included

CAUTION:

KEEP OUT OF REACH OF CHILDREN.

SEE SIDE AND BACK PANELS FOR ADDITIONAL INFORMATION.

FOR EXTERNAL USE ONLY

8 FL OZ (236 mL)

SMART SENSE LICE KILLING 
piperonyl butoxide, pyrethrum extract shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-866
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (PIPERONYL BUTOXIDE) PIPERONYL BUTOXIDE4 g  in 100 mL
PYRETHRUM EXTRACT (PYRETHRUM EXTRACT) PYRETHRUM EXTRACT0.33 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
C13-14 ISOPARAFFIN 
XANTHAN GUM 
WATER 
Product Characteristics
ColorYELLOW (cloudy to transparent, cream to straw) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49738-866-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:49738-866-341 BOTTLE in 1 CARTON
2236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G06/27/2011
Labeler - Kmart Corporation (008965873)

Revised: 04/2014
 
Kmart Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)