FDA.reportPublic FDA data

NATRALIA NATURALLY AUSTRALIAN ™ First Aid Cream

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

Apply a thin layer of cream and gently massage into affected area Use as required or as directed by a physician For best results use in conjunction with Natralia First Aid Spray

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
  • Do not use if tube seal is broken or appears tampered with
  • Always replace cap after use

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply a thin layer of cream and gently massage into affected area
  • Use as required or as directed by a physician
    • For best results use in conjunction with Natralia First Aid Spray

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Powder, Avocado Oil, Capric/Caprylic Triglycerides, Caprylyl Glycol (and) Sorbic Acid (and) Phenoxyethanol, Carica Papaya (Paw Paw) Extract, Cetearyl Alcohol, Cetyl Palmitate (and) Sorbitan Palmitate (and) Sorbitan Olivate, Stellaria Media (Chickweed) Extract, Theobroma Cacao Butter, Evening Primrose Oil, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Impatiens Cepenis (Jewelweed), Lavandula Angustifolia (Lavender) Oil, Butyrospermum Parkii (Shea Butter), Stearic Acid, Tocopheryl Acetate, Water, Zinc Oxide

Questions or Comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel - 1 oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATRALIA
NATURALLY AUSTRALIAN™

For the relief of skin irritations such as:

  • Cuts
  • Minor Burns
  • Abrasions
  • Irritation
  • Stings
  • Poison Ivy
  • Minor Rashes
  • Wounds

Net Wt 1oz (28g) e

Principal Display Panel - 1 oz Carton
Principal Display Panel - 1 oz Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43251-3363-82019-10-21C16284748780-1956f9ecf-cb10-621f-e053-dbdaa90a74adNATRALIA NATURALLY AUSTRALIAN ™ First Aid Cream
43251-3363-92019-10-21C16284748780-1956f9ecf-cb10-621f-e053-dbdaa90a74adNATRALIA NATURALLY AUSTRALIAN ™ First Aid Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43251-3363-8FLEXITOL FIRST AID28 g in 1 TUBECREAM281
43251-3363-8FLEXITOL FIRST AID1 in 1 CARTONCREAM11
43251-3363-9FLEXITOL FIRST AID0.85 g in 1 POUCHCREAM0.851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43251-3363FLEXITOL FIRST AID (ARNICA MONTANA FLOWER AND CHAMOMILE) CREAM [LADERMA TRADING PTY LTD]1Legacy NDC, 3 package rows20100312_b691f1c1-bd0a-48c8-b10f-048c15d69b79.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
43251-336343251-3363-8, 43251-3363-9

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
85dcf98b-ee55-40cc-a95a-e567ec4e53c4b691f1c1-bd0a-48c8-b10f-048c15d69b792010-01-29WarningsExact identifier
spl id: 85dcf98b-ee55-40cc-a95a-e567ec4e53c4
spl set id: b691f1c1-bd0a-48c8-b10f-048c15d69b79

Reported adverse events (FAERS/openFDA)#

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