FDA.reportPublic FDA data

Natralia Anti Fungal

Manufacturer
Lacorium Health USA Inc. | Denison Pharmaceuticals LLC | Australian Laboratory Services
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:23:31

Label at a glance#

ProductNatralia Anti Fungal
Active ingredientUndecylenic acid
Label structure10 sections

Indications and 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.

Dosage and administration

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 F...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Comments or questions?

OTC - QUESTIONS SECTION

Call Toll Free 1-877-687-2542

usainfo@natralia.com

www.natralia.com

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Undecylenic acidACTIVE INGREDIENTK3D86KJ24N1
Undecylenic acidACTIVE MOIETYK3D86KJ24N1
.Alpha.-Tocopherol Acetate, DL-INACTIVE INGREDIENTWR1WPI7EW81
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI6621
Hypromellose 2906 (4000 MPA.S)INACTIVE INGREDIENT5EYA69XGAT1
Isopropyl AlcoholINACTIVE INGREDIENTND2M4163021
Tea Tree OilINACTIVE INGREDIENTVIF565UC2G1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43251-336143251-3361-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Undecylenic acidK3D86KJ24NACTIB
Isopropyl AlcoholND2M416302IACT
Water059QF0KO0RIACT
Eucalyptus Oil2R04ONI662IACT
Hypromellose 2906 (4000 MPA.S)5EYA69XGATIACT
Tea Tree OilVIF565UC2GIACT
.Alpha.-Tocopherol Acetate, DL-WR1WPI7EW8IACT
Aloe Vera LeafZY81Z83H0XIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
.Alpha.-Tocopherol Acetate, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)HYPROMELLOSE 2906 (4000 MPA.S)5EYA69XGATSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
.Alpha.-Tocopherol Acetate, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8AEROSOL, FOAM / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)HYPROMELLOSE 2906 (4000 MPA.S)5EYA69XGATTABLET / ORAL50 mgExact identifier — unii candidate
6 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
Eucalyptus OilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)HYPROMELLOSE 2906 (4000 MPA.S)5EYA69XGATGRANULE, DELAYED RELEASE / ORAL33.2 mgExact identifier — unii candidate
6 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)HYPROMELLOSE 2906 (4000 MPA.S)5EYA69XGATCAPSULE / ORAL282 mgExact identifier — unii candidate
6 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)HYPROMELLOSE 2906 (4000 MPA.S)5EYA69XGATTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
6 equally ranked IID candidates
Hypromellose 2906 (4000 MPA.S)HYPROMELLOSE 2906 (4000 MPA.S)5EYA69XGATSUSPENSION / ORAL184 mgExact identifier — unii candidate
6 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
199871d6-9fc1-477d-9bb4-9b42794b0f70a993aec4-03ac-4de6-b2f1-d063ddf76d852020-06-22WarningsExact identifier
spl id: 199871d6-9fc1-477d-9bb4-9b42794b0f70
spl set id: a993aec4-03ac-4de6-b2f1-d063ddf76d85

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.