NATRALIA ANTI FUNGAL- undecylenic acid liquid

Natralia Anti Fungal by

Drug Labeling and Warnings

Natralia Anti Fungal by is a Otc medication manufactured, distributed, or labeled by Lacorium Health USA Inc., Scental Pacific Pty Ltd , Denison Pharmaceuticals LLC, Australian Laboratory Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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
• 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

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

Other information

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

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

www.natralia.com

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

FAST
DRYING

NDC: 43251-3361-1

natralia™
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)

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)