Label: LICEOUT- piperonyl butoxide and pyrethrum extract shampoo

  • NDC Code(s): 53247-124-01, 53247-124-02
  • Packager: Bob Barker Company Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    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)

    PRINCIPAL DISPLAY PANEL - 150 Sachet Case
  • INGREDIENTS AND APPEARANCE
    LICEOUT 
    piperonyl butoxide and pyrethrum extract shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53247-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Piperonyl butoxide (UNII: LWK91TU9AH) (Piperonyl butoxide - UNII:LWK91TU9AH) Piperonyl butoxide3 g  in 100 mL
    Pyrethrum Extract (UNII: ZUM06L90GV) (Pyrethrum Extract - UNII:ZUM06L90GV) Pyrethrum Extract0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    water (UNII: 059QF0KO0R)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53247-124-01150 in 1 CASE01/02/2022
    129.6 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:53247-124-023785 mL in 1 JUG; Type 0: Not a Combination Product01/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM03101/02/2022
    Labeler - Bob Barker Company Inc. (058525536)
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