FDA.reportPublic FDA data

NATRALIA NATURALLY AUSTRALIAN ™ First Aid Spray

Manufacturer
Laderma Trading Pty Ltd
Effective date
2010-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:52

Label at a glance#

ProductFLEXITOL FIRST AID
Active ingredientARNICA MONTANA FLOWER, CHAMOMILE
Label structure9 sections

Indications and uses

Helps promote healing of minor burns, poison ivy, abrasions and skin irritations Relieves sunburn and minor cuts

Dosage and administration

Rinse wound with warm water Spray onto affected area and absorb excess liquid with a cotton ball Use as required or as directed by a physician For best results use in conjunction with Natralia First Aid Cream

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Arnica Montana (6X H.P.U.S 0.2%)* Healing Agent
Matricaria Recutita (6X H.P.U.S 0.2%)* Healing Agent

* The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

  • Helps promote healing of minor burns, poison ivy, abrasions and skin irritations
  • Relieves sunburn and minor cuts

Warnings

WARNINGS SECTION

  • For External Use Only
  • Avoid contact with eyes, mouth, ears, nose or other sensitive areas. If contact occurs, rinse area thoroughly with water.
  • Keep out of reach of children
  • If pregnant or breast-feeding, ask a health care professional before use.
  • If condition worsens or does not improve after regular use of this product as directed, discontinue use and consult a physician.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rinse wound with warm water
  • Spray onto affected area and absorb excess liquid with a cotton ball
  • Use as required or as directed by a physician
  • For best results use in conjunction with Natralia First Aid Cream

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Powder, Calendula Officinalis (Calendula) Extract, Carica Papaya (Paw Paw) Extract, Citric Acid, Stellaria Media (Chickweed) Extract, Ethanol, Impatiens Cepenis (Jewelweed), Lavandula Angustifolia (Lavender) Oil, Water

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel - 2.1 fl oz Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATRALIA
NATURALLY AUSTRALIAN™

First Aid Spray

FOR THE RELIEF OF SKIN
IRRITATIONS & CUTS

NATURAL HOMEOPATHIC ALTERNATIVE

Contains 25.1% Ethanol w/w

Net 2.1 fl oz (60mL) e

Principal Display Panel - 2.1 fl oz Label
Principal Display Panel - 2.1 fl oz Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43251-3353-72019-10-21C16284748780-1956f9ecf-cc06-621f-e053-dbdaa90a74adNATRALIA NATURALLY AUSTRALIAN ™ First Aid Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43251-3353-7FLEXITOL FIRST AID1 in 1 CARTONSPRAY11
43251-3353-7FLEXITOL FIRST AID60 mL in 1 TUBESPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43251-3353FLEXITOL FIRST AID (ARNICA MONTANA FLOWER AND CHAMOMILE) SPRAY [LADERMA TRADING PTY LTD]1Legacy NDC, 2 package rows20100312_9d366317-c1e5-41e8-bc8f-f165a4fa06f0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANA FLOWERACTIVE INGREDIENTOZ0E5Y15PZ1
CHAMOMILEACTIVE INGREDIENTFGL3685T2X1
ARNICA MONTANA FLOWERACTIVE MOIETYOZ0E5Y15PZ1
CHAMOMILEACTIVE MOIETYFGL3685T2X1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43251-335343251-3353-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
CHAMOMILEFGL3685T2XACTIB

Source Document#

Source XML

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
34e2e253-4b67-42aa-97a9-7e1ec09bac1c9d366317-c1e5-41e8-bc8f-f165a4fa06f02010-01-29WarningsExact identifier
spl id: 34e2e253-4b67-42aa-97a9-7e1ec09bac1c
spl set id: 9d366317-c1e5-41e8-bc8f-f165a4fa06f0

Reported adverse events (FAERS/openFDA)#

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