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Mata Piojos (Apex International Mfg)

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SHAMPOO 60 g in 1 BOTTLE, PLASTIC (57501-865-02) Label Information

Complete Mata Piojos Information

  • PRINCIPAL DISPLAY PANEL

    Drug Facts


    Active Ingredients        Purpose
    Pyrethrins 0.33%
    Piperonyl Butoxide 4%........Pedicullicide

    Uses
    For the treatment of Head, Body, Pubic (Crab) Lice.

    Warnings
    For external use only.

    Allergy alert:
    Use with caution on persons allergic to ragweed.

    Do not use

    • near eyes or permit contact with mucous membranes, such as inside the nose, mouth, or vagina.

    Ask a doctor before use if you have
    • Skin irritation or infection
    • Infected eyebrows or eyelashes

    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center immediately.

    Directions

    • SHAKE WELL BEFORE USE
    • Use on DRY hair.
    • Apply to affected area until all hair is thoroughly wet with product
    • Allow product to remain on for 10 minutes but no longer.

    Test Submit Image


  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Pyrethrum Extract equivalent to 0.33% Pyrethrins

    Piperonyl Butoxide 4% equivalent to min. 3.2%

    (butylcarbityl)(6-propylpiperonyl) ether and 0.8% related compounds.



  • INGREDIENTS AND APPEARANCE
    MATA PIOJOS  A PEDICULICIDE LOW FOAMING
    pyrethrum extract, piperonyl butoxide shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57501-865
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Pyrethrum Extract (UNII: ZUM06L90GV) (Pyrethrum Extract - UNII:ZUM06L90GV) Pyrethrum Extract .12 g  in 60 g
    Piperonyl Butoxide (UNII: LWK91TU9AH) (Piperonyl Butoxide - UNII:LWK91TU9AH) Piperonyl Butoxide 2.4 g  in 60 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R) 39.78 g  in 60 g
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 14.2 g  in 60 g
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 3.5 g  in 60 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57501-865-02 60 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358G 04/23/2010
    Labeler - Apex International Mfg (015226132)
    Registrant - Apex International Mfg (015226132)
    Establishment
    Name Address ID/FEI Business Operations
    Apex International Mfg 015226132 manufacture