LET Thursday Plantation Labs LTD Australia Vol by FDADocs

VIEWS: 28 PAGES: 5

									1 November 2001                                                                      Health   from   Nature


                                                                                     Thursday Plantation
                                                                                     Laboratories Limited
                                                                                        ABN 17002833141



Food and Drug Administration
5630 Fishers Lane r. 1061
Rockville, MD 20852
USA




Dear Sir/Madam,

Re.:   Thursday Plantation Laboratories Ltd
       Thursday Plantation Tea Tree Ointment and Vita-                        E
       Size: 1.76 oz (50 g)

We would like to request exemption from your requirement of 2 1CFR20 1.66 based
on the following circumstances presented. It is impracticable due to:
        1.                                            . da“=z,,all .-,, ..“+,“.,>,.*
                                                              .l, the
                The label size is too small to @bar lines and e.,~*/.r wording in the font
                                                            I.,                  /
                                                                               _,*^,
                size required.

Please find enclosed our proposed label artwork for this product.

Should you have any questions and need more information, please contact our
regulatory consultant, Mrs Norma Daliva-Banks at 559-346-0233, California, USA.

Your kind consideration of this matter and immediate action are greatly appreciated.

Thanking you.

Furs   sincerely




Robert Riedl
Technical Manager
Regulatory Affairs

cc. Norma Daliva-Banks




                                                                                                        Quality
                                                                                                     Endorsed
                             DDKfir   Uinhmmv   RAina   NSW   7478 Allstdia                           Company
                        I




  097467064454
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-           _
  DrugFacts
  ActiveIngredient grarn):TeaTree
                 (per                  Altemifolii)Oil SOmg _ _ _ _ _ _ __ Puwse Antiseptic
                               (Melaleuca                 _
                                     rash,       dry             lips
  Usesprotectscuts,abnsions,gravei cracked skin,chapped andother minorwoundsagainst
          by
  invasion infection. bnings for externaluseoniy.When              tJ&
                                                            using productavoid             with
                                                                                    ConMct eyes.
  If contactoccurs,
                  rinse+~oroughiy water.
                                   with      Stop and aska doctor l in case deeppuncturewounds
                                                                             of
  or seriousbumsl if redness,                        or        or          occurs.ikep out of reach
                            irritationor painpersists increases if infection
  of children. swallowed,get
               If            medical or contacta poisoncontrolcenterrightaway.
                                      help                                         Directionsspread
    endyoverinfectedskinareatwo or threetimesper day.   Other lnfonnationstore roomtemperawre.
                                                                                at
  f no&e Ingredients    Parr&n, Ceatearyl Alcohol,Sodium                        Acetate(VitaminE),
                                                         LaurylSulfate,Tocopheryi
  Thursday Plantation            Ltd.
                     Laboratories Ballina          www.ttwsdayplantation.com
                                           Australia                             Australii Made
4 Distributed the USAb)cNaturalOrganics Melville I I747
             in                            Inc.       NY
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