NATRALIA ANTI FUNGAL- undecylenic acid liquid
Lacorium Health USA Inc.

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.

----------

natralia™
NATURALLY AUSTRALIAN
anti-fungal
liquid

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)

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

NATRALIA ANTI FUNGAL
undecylenic acid liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43251-3361-1	1 in 1 CARTON	01/03/2009	05/31/2022
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333C	01/03/2009	05/31/2022

Labeler - Lacorium Health USA Inc. (111254392)

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

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

Revised: 6/2020

Document Id: 199871d6-9fc1-477d-9bb4-9b42794b0f70

Set id: a993aec4-03ac-4de6-b2f1-d063ddf76d85

Version: 4

Effective Time: 20200622

Lacorium Health USA Inc.

natralia™ NATURALLY AUSTRALIAN anti-fungal liquid