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Name:Natralia Anti Fungal
Manufacturer:Laderma Trading Pty Ltd
Category:Over-the-counter (OTC) Marketed Drugs


natralia™ NATURALLY AUSTRALIAN anti-fungal liquid

NATRALIA ANTI FUNGAL - undecylenic acid liquid 
Laderma Trading Pty Ltd

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.

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natralia
NATURALLY AUSTRALIAN
anti-fungal
liquid

Drug Facts

Active ingredient

Undecylenic Acid 25%

Purpose

Anti-Fungal

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.

Warnings

  • For External Use Only

  • 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
  • If swallowed, get medical help or contact a Poison Control Center right away

  • Discontinue use and consult a doctor if irritation occurs or there is no improvement within 4 weeks

  • Avoid contact with eyes

Other information

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

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

Inactive ingredients

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

Comments or questions?

Call Toll Free 1-877-687-2542
usainfo@natralia.com.au
www.natralia.com.au/usa

PRINCIPAL DISPLAY PANEL - 30 mL Carton

FAST
DRYING

natralia
NATURALLY AUSTRALIAN

anti-fungal
liquid

natural alternative

Treats Fungus

Easy brush-on APPLICATOR

Net 1 fl oz (30 mL)

Principal Display Panel - 30 mL Carton

NATRALIA ANTI FUNGAL 
undecylenic acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43251-3361
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Undecylenic acid (Undecylenic acid) Undecylenic acid 250 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Isopropyl Alcohol  
Water  
Eucalyptus Oil  
Hypromellose 2906 (4000 MPA.S)  
Tea Tree Oil  
.Alpha.-Tocopherol Acetate, DL-  
Aloe Vera Leaf  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43251-3361-1 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (43251-3361-1)

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

Labeler - Laderma Trading Pty Ltd (758651624)

Revised: 04/2011 Laderma Trading Pty Ltd



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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