RID LICE ELIMINATION ESSENTIALS- piperonyl butoxide, pyrethrum extract kit

RID Lice Elimination Essentials by

Drug Labeling and Warnings

RID Lice Elimination Essentials by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Shampoo

ACTIVE INGREDIENT

Active ingredients

Piperonyl butoxide (4%)

Pyrethrum extract (equivalent to 0.33% pyrethrins)

PURPOSE

Purpose

Lice treatment

Uses

Uses treats head, pubic (crab), and body lice

WARNINGS

Warnings

For external Use only

DO NOT USE

Do not use

· near the eyes

· inside the nose, mouth, or vagina

· on lice in eyebrows or eyelashes. See a doctor if lice are present

in these areas.

· if you have ever had an allergic reaction to this product or any of its

ingredients

ASK DOCTOR

Ask a doctor before use if you are allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

WHEN USING

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

● 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 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 SAFETY INFORMATION

Other information

● keep carton for important product information

● see Consumer Information Insert for additional information

● avoid excessive heat

INACTIVE INGREDIENT

Inactive ingredients ammonium laureth sulfate, dehydrated alcohol, fragrance, isopropyl alcohol, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water

SPL UNCLASSIFIED SECTION

RID Lice & Egg Comb Out Spray

Use

Use

RID® Lice & Egg Comb-Out Spray detangles hair in order to make lice and egg comb-out easier.

WARNINGS

Warnings

For external use only. Keep out of reach of children. Avoid contact with eyes. Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Directions

Directions For Use

● Before using, read Consumer Information Insert for complete directions.

● Use AFTER shampooing with RID® Lice Killing Shampoo.

● Towel dry hair. Apply a small amount of RID® Lice & Egg Comb-Out Spray and use a wide-toothed

comb to remove any tangles.

● Comb out the dead lice, eggs, and nits, one small section at a time, with the enclosed RIDvantage® Jr.

Lice Comb. (See insert for additional combing instructions). This step is very important.

● Use additional RID® Lice & Egg Comb-Out Spray to remove tangles, if needed, during the comb-out

process.

● After you have combed entire head, rinse hair thoroughly with warm water. Disinfect combs with hot

water (130ºF).

Other Information

Other Information

● It is important to wash in hot water (130ºF) all clothing, bedding, towels, and hair products (combs,

brushes) used by infested persons in the two days prior to treatment.

● Dry clean non-washable fabrics.

● To eliminate infestation of furniture and bedding that cannot be washed or dry cleaned, a multi-use lice

spray such as RID® Home Lice, Bedbug & Dust Mite Spray may be used.

● RID® Lice & Egg Comb-Out Spray does not kill lice or their eggs. Use this product only after treating

with RID® Lice Killing Shampoo.

● Store in a cool, dry place. Keep from freezing.

Ingredients

Ingredients

Water, Glycerin, Propylene Glycol, Polysorbate 20, Cetrimonium Chloride, Amodimethicone, Phenoxyethanol, Fragrance, DL Panthenol, Trideceth-12, Methylchloroisothiazolinone, Methylisothiazolinone.

QUESTIONS

Questions?

1-800-RID-LICE (1-800-743-5423) (Mon – Fri 9AM – 8PM EST)

PRINCIPAL DISPLAY PANEL

Questions or comments? 1-800-RID-LICE (1-800-743-5423) (Mon – Fri 9AM – 8PM EST) www.ridlice.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RID LICE ELIMINATION ESSENTIALS 
piperonyl butoxide, pyrethrum extract kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-9070

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-9070-01	1 in 1 CARTON; Type 0: Not a Combination Product	09/28/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE, SPRAY	59 mL

Part 1 of 2

RID LICE KILLING 
iperonyl butoxide, pyrethrum extract shampoo

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV)	PYRETHRUM EXTRACT	3.3 mg  in 1 mL
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH)	PIPERONYL BUTOXIDE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	09/28/2016

Part 2 of 2

RID LICE AND EGG COMB OUT 
tonics, dressings, and other hair grooming aids spray

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	DISODIUM SEC-TRIDECETH-12 SULFOSUCCINATE (UNII: 3C19U43ACC)
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
INGR	AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)
INGR	METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		09/23/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	09/28/2016

Labeler - Bayer HealthCare LLC. (112117283)