ECO.KID (PIPERONYL BUTOXIDE) SHAMPOO [FRAVIN PTY LTD]

ECO.KID (PIPERONYL BUTOXIDE) SHAMPOO [FRAVIN PTY LTD]
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NDC 76479-4403-1
Set ID d9cda91f-e832-4220-a874-124495a15716
Category HUMAN OTC DRUG LABEL
Packager Fravin Pty Ltd
Generic Name
Product Class
Product Number
Application Number PART358G
  • 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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