Eco.kid
FDA Label NDC 76479-4403

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fravin Pty Ltd for the product Eco.kid (NDC 76479-4403). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - 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

Otc - Purpose

Lice Treatment

Warnings

Warnings

For external use only.

Otc - Do Not Use

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.

Otc - When Using

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

Otc - Ask Doctor

Ask a doctor before use if you are

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

Otc - Stop Use

Stop use and ask doctor if

  • Eye irritation occurs
  • Breathing difficulty occurs
  • Skin or scalp irritation continues or infection occurs

Otc - Keep Out Of Reach Of Children

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.

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* Please review the disclaimer below.