Label: ECO.KID- piperonyl butoxide shampoo
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated November 28, 2011
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- ACTIVE INGREDIENT
For external use only.
Do Not Use:
- Near eyes
- Inside the nose, mouth, or vagina
- On lice in eyebrows or eyelashes.
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
- INDICATIONS & USAGE
- STORAGE AND HANDLING
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
- Important: Read warnings before use
- 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
- 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.
- Use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand using a
- 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.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
piperonyl butoxide shampoo
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76479-4403 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE 2 mL in 100 mL PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT 0.17 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76479-4403-1 1 in 1 CARTON 1 59 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358G 10/01/2011 Labeler - Fravin Pty Ltd (752587444) Establishment Name Address ID/FEI Business Operations Fravin Pty Ltd 752587444 manufacture