Label: ECO.KID- piperonyl butoxide shampoo

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 28, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients                                    Purpose

    Piperonyl butoxide 1X                                       Lice and egg treatment

    Pyrethrum 1X                                                   Lice and egg treatment

    (Piperonyl butoxide 20mg/g) 2%                        Lice and egg treatment

    (Pyrethrum 1.7mg/g) 0.17%                              Lice and egg treatment

  • PURPOSE

    Lice Treatment

  • WARNINGS

    Warnings

    For external use only.

    Do Not Use:

    • Near eyes
    • Inside the nose, mouth, or vagina
    • On lice in eyebrows or eyelashes.
    See a doctor if lice are present in these areas.

    When using this product

    • Keep eyes tightly closed and protect eyes with a wash cloth or towel.
    • If product gets into eyes flush with water right away
    • Scalp itching and redness may occur

    Ask a doctor before use if you are

    • Allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

    Stop use and ask doctor if

    • Eye irritation occurs
    • Breathing difficulty 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 Centre right away.
  • INDICATIONS & USAGE

    Uses treats head lice and body lice

  • STORAGE AND HANDLING

    Other Information

    • For more information read the enclosed Consumer Information Leaflet.
    • Protect from excessive heat.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Cocos nucifera (Coconut) Oil*, D'Limonene (Orange) Oil*, Eucalyptus Globulus (Southern
    Blue Gum) Oil*, Glycerine*, Glycine soja (Soya Bean) Oil*, Leptospermum petersonii
    (Lemon Scented Tea Tree) Oil*, Maurita Flexuosa Fruit (Buriti) Oil*, Melaleuca alternifolia
    (Tea Tree) Oil*, Melaleuca quinquenervia (Broad Leaf Paperbark Gum) Oil*.
    *Ingredients from Organic Farming.

  • DOSAGE & ADMINISTRATION

    Directions

    • Important: Read warnings 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 back 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 thoroughly to dry 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
    • 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 or 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 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.
  • PRINCIPAL DISPLAY PANEL


    eco.kid label


  • INGREDIENTS AND APPEARANCE
    ECO.KID 
    piperonyl butoxide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76479-4403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE2 mL  in 100 mL
    PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.17 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    MELALEUCA QUINQUENERVIA LEAF OIL (UNII: 22K2F1YSHD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76479-4403-11 in 1 CARTON
    159 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G10/01/2011
    Labeler - Fravin Pty Ltd (752587444)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fravin Pty Ltd752587444manufacture
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