Label: LICEMD  TREATMENT- pyrethrum extract and piperonyl butoxide gel 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Piperonyl butoxide (4%) Lice treatment
    Pyrethrum extract (equivalent to pyrethrins 0.33%) Lice treatment
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  • Uses

    treats head, pubic (crab), and body lice

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  • 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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control center right away.

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  • Directions

    • Important: Read warnings before use.
      Read leaflet inside carton for complete directions 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 this product thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck.
      • allow this product to remain on hair or other affected area for 10 minutes, but no longer
      • wash area thoroughly with warm water and soap or shampoo
      • for head lice, towel dry hair and comb out tangles

      Remove lice and their eggs (nits)

      • use a fine-tooth comb or the 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 with this product 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

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  • Other information

    • store at 20-25°C (68-77°F). Avoid excessive heat.
    • keep carton for important product information
    • see leaflet inside carton for additional information
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  • Inactive ingredients

    butylated hydroxytoluene, carboxymethylcellulose sodium, dimethicone, fragrance, hydroxyethylcellulose, methylchloroisothiazolinone, methylisothiazolinone, petroleum distillates, water

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  • Questions?

    1-866-252-5327.
    You may also report side effects to this phone number.

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  • LiceMD® Comb

    Directions

    For Head Lice

    Please read the leaflet for complete directions before use.

    Use AFTER LiceMD treatment gel and shampooing steps.

    • comb out the dead lice, eggs, and nits with the enclosed LiceMD comb. Please read the entire leaflet for complete directions. This step is very important.
    • start at the top of the head, comb one section at a time and it is important to get the teeth of the comb very close to the scalp. Combing can take over an hour.
    • if hair dries before combing, dampen slightly with warm water
    • soak all combs, bobby pins, and hair clips in hot water [above 54°C (130°F)] after combing
    • check daily for any lice/nits that you have missed
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  • Throw-Away Gloves

    • 100% nitrile
    • powder-free
    • latex-free
    • non-sterile
    • single-use
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  • SPL UNCLASSIFIED SECTION

    Dist. by: Reckitt Benckiser
    Parsippany, NJ 07054-0224

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    LiceMD®
    TREATMENT GEL

    SATISFACTION GUARANTEED
    100% GUARANTEE
    OR YOUR MONEY BACK**

    NDC 63824-908-00

    LiceMD®
    TREATMENT GEL

    Pyrethrum Extract
    (Equivalent to 0.33% Pyrethrins)
    with Piperonyl Butoxide 4%
    Lice Treatment

    KILLS LICE &
    ELIMINATES
    100% of THEIR EGGS*

    TREAT - kill lice

    COMB - eliminate
    100% lice eggs

    CONTAINS:

    1 Lice Killing Gel 4 FL OZ (118mL)
    1 Comb
    2 Pairs of
      Throw-Away
      Gloves

    *The LiceMD Comb
      eliminated 100%
      lice eggs in
      laboratory testing

    Principal Display Panel - 118 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    LICEMD   TREATMENT
    pyrethrum extract and piperonyl butoxide gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-900
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Pyrethrum Extract (Pyrethrum Extract) Pyrethrum Extract 0.33 g  in 100 mL
    Piperonyl Butoxide (Piperonyl Butoxide) Piperonyl Butoxide 4 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    butylated hydroxytoluene  
    carboxymethylcellulose sodium  
    dimethicone  
    methylchloroisothiazolinone  
    methylisothiazolinone  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-900-64 1 in 1 CARTON
    1 118 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part358G 11/01/2012
    Labeler - Reckitt Benckiser LLC (094405024)
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