ECO.KID - piperonyl butoxide shampoo 
Fravin Pty Ltd

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

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

Adults and children 2 years and over.

Inspect

Treat

Remove lice and their eggs (nits)

Children under 2 years: ask a doctor.


eco.kid label


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

Revised: 11/2011
Document Id: f33bb874-d16e-4926-b066-a323b9b3c161
Set id: d9cda91f-e832-4220-a874-124495a15716
Version: 3
Effective Time: 20111128
 
Fravin Pty Ltd