Available Formats

• SPL UNCLASSIFIED SECTION

  Drug Facts

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• Active ingredients

  Undecylenic Acid 25%

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• Purpose

  Anti-Fungal

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• Uses

  For the treatment of: most Athlete's Foot (Tinea Pedis), Ringworm (Tinea Corporis). For relief of: itching, scaling, cracking, burning, redness, soreness, irritation and discomfort which may accompany these conditions.

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• Warnings

  • For external use only
  • Discontinue use and consult a doctor if irritation occurs or there is no improvement within 4 weeks
  • Avoid contact with eyes
  • Do not use on children under 2 years of age unless directed by a doctor
  • Extremely flammable
  • Keep away from fire or flame
  • Avoid smoking during use and until product has dried

  • Keep out of reach of children

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• Directions

  • Read all directions and warnings before use. Clean affected area with soap and warm water and dry thoroughly. Apply a thin layer of Natralia Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctor.
  • For Athlete's Foot, pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For Athlete's Foot and Ringworm use daily for 4 weeks. If condition persists longer, consult a doctor.
  • Persons under 18 years of age or those with sensitive skin should use only as directed by a doctor
  • Supervise children in the use of this product
  • This product is not effective on the scalp or nails
  • Replace cap and tighten after each use

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• Other information

  • Store between 50° – 86°F in a dry place

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• Inactive ingredients

  Isopropyl Alcohol, Water, Eucalyptus Globulus Leaf Oil, Hydroxypropyl Methylcellulose, Melaleuca Alternifolia (Tea Tree) Oil, Tocopherol, Aloe Barbadensis Leaf Juice

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• Comments or questions?

  Call Toll Free 1-877-687-2542

  usainfo@natralia.com

  www.natralia.com

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• PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

  FAST
  DRYING

  NDC: 43251-3361-1

  natraliaâ„¢
  NATURALLY AUSTRALIAN

  Anti-Fungal
  Liquid

  CLINICALLY PROVEN FORMULA

  • Relieves itching,
    cracking & burning
  • Enriched with
    Tea Tree &
    Eucalyptus Oils
  • Easy brush-on
    applicator

  Net Wt 1 fl oz (30ml)

  

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• INGREDIENTS AND APPEARANCE

  NATRALIA ANTI FUNGAL  undecylenic acid liquid

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43251-3361 Route of Administration TOPICAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Undecylenic acid (UNII: K3D86KJ24N) (Undecylenic acid - UNII:K3D86KJ24N) Undecylenic acid 250 mg  in 1 mL

  Inactive Ingredients Ingredient Name Strength Isopropyl Alcohol (UNII: ND2M416302)   Water (UNII: 059QF0KO0R)   Eucalyptus Oil (UNII: 2R04ONI662)   Hypromellose 2906 (4000 MPA.S) (UNII: 5EYA69XGAT)   Tea Tree Oil (UNII: VIF565UC2G)   .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)   Aloe Vera Leaf (UNII: ZY81Z83H0X)

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43251-3361-1 1 in 1 CARTON 01/03/2009 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 01/03/2009

  Labeler - Lacorium Health USA Inc. (111254392)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Scental Pacific Pty Ltd		744482427	MANUFACTURE(43251-3361) , PACK(43251-3361) , LABEL(43251-3361) , ANALYSIS(43251-3361)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Denison Pharmaceuticals LLC		001207208	MANUFACTURE(43251-3361) , LABEL(43251-3361) , ANALYSIS(43251-3361) , PACK(43251-3361)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Australian Laboratory Services		758817084	ANALYSIS(43251-3361)

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