LICEOUT- piperonyl butoxide and pyrethrum extract shampoo

LiceOut by

Drug Labeling and Warnings

LiceOut by is a Otc medication manufactured, distributed, or labeled by Bob Barker Company Inc., Chem-Tech, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

*Piperonyl Butoxide, Technical...........................................................................................3.0% Pyrethrum Extract..............................................................................................................0.3%

*Equivalent to min. 2.4% (butylcarbityl) (6-propylpiperonyl) ether and 0.6% related compounds.

Active Ingredients	Purpose
Piperonyl Butoxide, Technical 3.0%	Lice Treatment
Pyrethrum Extract 0.3%	Lice Treatment
*Equivalent to min. 2.4% (butylcarbityl) (6-propylpiperonyl) ether and 0.6% related compounds.

INDICATIONS & USAGE

Uses: Treats head, pubic (crab) and body lice.

WARNINGS

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. Do not freeze. Do not reuse original container.
Children under 2 years ask a doctor

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.
• if product gets in eyes, flush with water right away
• scalp itch-ing 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

Children under 2 yearsask a doctor.

Caution

Keep Out of the Reach of Children

Directions

Shake Well Before Using

Adults and children 2 years and over.

Treat

• Apply thoroughly to 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.
• Check daily for any lice/nits.
• 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.

Other Information

Other Infromation
See insert in carton for additional information.

Inactive Ingredients

Water, Octylphenoxypolethoxyethanol, Piperonyl Butoxide, Benzyl Alcohol, C 13-14 Isoparaffin, Pyrethrum Extract.

SPL UNCLASSIFIED SECTION

Distributed By: Bob Barker Company, Inc.
7925 Purfoy Road, Fuquay-Varina, NC 27526

PRINCIPAL DISPLAY PANEL - 150 Sachet Case LICEOUT

LICEOUT

Non-foaming Shampoo
Liquid Lice Treatment for Human Use

Kills
Head Lice (Pediculus Humanus capitis DeG)
Body Lice (Pediculus Humanus Humanus L.)
Pubic (Crab) Lice (Phthirus pubis L.)

Caution
Keep Out of the Reach of Children

Contents: 1 FL. OZ. (29.6 mL)

PRINCIPAL DISPLAY PANEL

LICEOUT

Non-foaming Shampoo
Liquid Lice Treatment for Human Use

Kills
Head Lice (Pediculus Humanus capitis DeG)
Body Lice (Pediculus Humanus Humanus L.)
Pubic (Crab) Lice (Phthirus pubis L.)

Caution
Keep Out of the Reach of Children

Contents: 128 FL. OZ. (3785.4 mL)

INGREDIENTS AND APPEARANCE

LICEOUT 
piperonyl butoxide and pyrethrum extract shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53247-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH)	PIPERONYL BUTOXIDE	3 g  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV)	PYRETHRUM EXTRACT	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53247-124-01	150 in 1 CASE	01/02/2022	09/05/2025
1		29.6 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 53247-124-02	3785 mL in 1 JUG; Type 0: Not a Combination Product	01/02/2022	04/11/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/02/2022	04/11/2026

Labeler - Bob Barker Company Inc. (058525536)