Eco.kid

Dosage form: shampoo
Ingredients: PIPERONYL BUTOXIDE 2mL in 100mL, PYRETHRUM EXTRACT 0.17mL in 100mL
Labeler: Fravin Pty Ltd
NDC Code: 76479-4403

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.

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

Lice Treatment

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.

Uses treats head lice and body lice

Other Information

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

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.

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.



ECO.KID 
piperonyl butoxide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76479-4403
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (PIPERONYL BUTOXIDE) PIPERONYL BUTOXIDE2 mL  in 100 mL
PYRETHRUM EXTRACT (PYRETHRUM EXTRACT) PYRETHRUM EXTRACT0.17 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL 
ORANGE OIL 
EUCALYPTUS OIL 
GLYCERIN 
SOYBEAN OIL 
LEPTOSPERMUM PETERSONII LEAF OIL 
MAURITIA FLEXUOSA FRUIT OIL 
TEA TREE OIL 
MELALEUCA QUINQUENERVIA LEAF OIL 
Packaging
#Item CodePackage Description
1NDC:76479-4403-11 BOTTLE (BOTTLE) 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/FEIOperations
Fravin Pty Ltd752587444manufacture

Revised: 11/2011
 
Fravin Pty Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)