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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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.

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.
• 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 years ask 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

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

LICE OUT™

SHAMPOO LICE TREATMENT

150 Sachets—Total Net Weight 180.8 oz (11.3 lbs) (5.12 KG)

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
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M031	01/02/2022

Labeler - Bob Barker Company Inc. (058525536)