Label: LICE MD COMPLETE- pyrethrum extract and piperonyl butoxide

  • 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 09/13

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

  • SPL UNCLASSIFIED SECTION

    LiceMD® Treatment Gel

    Drug Facts

    Close
  • ACTIVE INGREDIENT

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

    treats head, pubic (crab), and body lice

    Close
  • 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.

    Close
  • 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
    Close
  • 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
    Close
  • Inactive ingredients

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

    Close
  • Questions?

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

    Close
  • SPL UNCLASSIFIED SECTION

    LiceMD Shampoo (Non-medicated)

    Important: Read leaflet inside carton for complete directions before use.

    For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children.

    Close
  • Directions

    • for use after treatment with LiceMD® Treatment Gel
      • rinse hair with warm water and apply LiceMD Shampoo (Non-Medicated)
      • thoroughly massage shampoo into the scalp and work into a lather
      • be sure to shampoo behind ears and on back of neck too
      • rinse thoroughly with warm water
      • repeat if necessary to remove all traces of LiceMD® Treatment Gel
      • towel dry hair and comb out tangles with a wide-tooth comb
    • This shampoo does not kill lice or their eggs (nits). Use this shampoo only after using the LiceMD® Treatment Gel contained in this carton or another similar lice treatment product.
    Close
  • Ingredients

    water, sodium laureth sulfate, sodium chloride, cocamidopropyl betaine, cocamide DEA, lauramide DEA, fragrance, diethanolamine, glycerin, polysorbate-20, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, propylene glycol, dimethicone

    Close
  • Questions?

    1-866-252-5327
    store at 20-25°C (68-77°F).

    Close
  • SPL UNCLASSIFIED SECTION

    LiceMD Shampoo Made in Canada
    Throw-away Gloves Made in China

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

    Close
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    SATISFACTION GUARANTEED
    100%
    GUARANTEE

    OR YOUR MONEY BACK**

    LiceMD®

    COMPLETE KIT

    NDC 63824-916-00

    LiceMD®

    COMPLETE KIT

    with 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

    WASH - clean hair

    KIT CONTAINS:
    1 Lice Killing Gel 4 FL OZ (118mL)
    1 Comb
    1 Shampoo (Non medicated) 4 FL OZ (118mL)
    2 Pairs of gloves

    * The LiceMD® comb eliminated 100% lice eggs in laboratory testing

    Principal Display Panel - Kit Carton
    Close
  • INGREDIENTS AND APPEARANCE
    LICE MD  COMPLETE
    pyrethrum extract and piperonyl butoxide kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-916
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-916-00 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, DISPENSING 118 mL
    Part 2 1 BOTTLE 118 mL
    Part 1 of 2
    LICEMD  TREATMENT
    pyrethrum extract and piperonyl butoxide gel
    Product Information
    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
    1 118 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
    Part 2 of 2
    LICEMD  (NON-MEDICATED)
    shampoos (non-coloring) shampoo
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR water  
    INGR sodium laureth-3 sulfate  
    INGR citric acid monohydrate  
    INGR cocamidopropyl betaine  
    INGR sodium chloride  
    INGR PEG-150 pentaerythrityl tetrastearate  
    INGR PPG-2 hydroxyethyl cocamide  
    INGR polysorbate 20  
    INGR edetate sodium  
    INGR magnesium nitrate  
    INGR propylene glycol  
    INGR sodium hydroxide  
    INGR methylchloroisothiazolinone  
    INGR magnesium chloride  
    INGR dimethicone  
    INGR methylisothiazolinone  
    INGR edetate trisodium  
    INGR sodium ferrocyanide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 11/01/2012
    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)
    Close