Rid Lice Elimination Essentials Kit

Rid Lice Elimination Essentials Kit
SPL v2
SPL
SPL Set ID 3d927d10-6d82-1cab-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrethrum Extract (3.3 mg) Piperonyl Butoxide (40 mg)
Inactive Ingredients
Alcohol Isopropyl Alcohol Polyquaternium-10 (1000 Mpa.s At 2%) Ammonium Laureth-2 Sulfate Hydrogenated Castor Oil Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-09-28

Description

Drug Facts Shampoo


Medication Information

Warnings and Precautions

Warnings

For external Use only

Description

Drug Facts Shampoo

Use

Use

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

Uses

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

Section 42229-5

Drug Facts

Shampoo

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

● breathing difficulty occurs

● eye irritation occurs

● skin or scalp irritation continues or infection occurs

Section 50567-7

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

Section 50569-3

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

Section 50570-1

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

Section 51727-6

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

Section 51945-4

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

Section 53413-1

Questions?

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

Section 55105-1

Purpose

Lice treatment

Section 55106-9

Active ingredients

Piperonyl butoxide (4%)

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Section 60561-8

Other information

● keep carton for important product information

● see Consumer Information Insert for additional information

● avoid excessive heat

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

Ingredients

Ingredients

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

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.


Structured Label Content

Use

Use

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

Uses

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

Warnings and Precautions (34071-1)

Warnings

For external Use only

Section 42229-5 (42229-5)

Drug Facts

Shampoo

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

● breathing difficulty occurs

● eye irritation occurs

● skin or scalp irritation continues or infection occurs

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions?

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

Section 55105-1 (55105-1)

Purpose

Lice treatment

Section 55106-9 (55106-9)

Active ingredients

Piperonyl butoxide (4%)

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Section 60561-8 (60561-8)

Other information

● keep carton for important product information

● see Consumer Information Insert for additional information

● avoid excessive heat

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

Ingredients

Ingredients

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

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.


Advanced Ingredient Data


Raw Label Data

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