FDA.reportPublic FDA data

natralia™ NATURALLY AUSTRALIAN acne cream

Manufacturer
LaCorium Health International Pty Ltd
Effective date
2012-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:04:13

Label at a glance#

ProductNatralia Acne
Active ingredientCALENDULA OFFICINALIS FLOWER, CALCIUM CARBONATE, PULSATILLA VULGARIS
Label structure9 sections

Indications and uses

Use on affected areas to clear and prevent breakouts. Suitable for use on the face and body

Dosage and administration

Use morning and night After cleansing with Natralia Acne Wash , cover the entire affected area with a thin layer of Natralia Acne 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
Calcarea Carbonica (3× HPUS 0.5%)* Acne Control
Pulsatilla Vulgaris (3× HPUS 0.5%)* Acne Control
Calendula Officinalis (6× HPUS 1%)* Acne Control

* 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

  • Use on affected areas to clear and prevent breakouts.
  • Suitable for use on the face and body

Warnings

WARNINGS SECTION

  • For External Use Only

OTC - STOP USE SECTION

  • If condition worsens or does not improve after regular use of this product as directed or if local irritation or rash occurs, discontinue use and consult a physician

OTC - WHEN USING SECTION

  • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children

OTC - WHEN USING SECTION

  • Avoid unnecessary sun exposure

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use morning and night
  • After cleansing with Natralia Acne Wash, cover the entire affected area with a thin layer of Natralia Acne Cream.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Capric/Caprylic Triglycerides, Caprylyl Glycol (and) Sorbic Acid (and) Phenoxyethanol, Cetyl Palmitate (and) Sorbitan Palmitate (and) Sorbitan Olivate, Chamomilla Recutita (Chamomile) Extract, Garcinia Mangostana Extract, Glycerine, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Distillate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyltaurate Copolymer (and) Squalane (and) Polysorbate 60, Lactic Acid, Melaleuca Alternifolia (Tea Tree) Oil, Rosa Canina Fruit (Rose Hip) Oil, Sodium Hydroxide, Stearic Acid, Water, Zinc PCA

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 - 56g Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

natralia™
NATURALLY AUSTRALIAN

acne cream

natural homeopathic alternative

Treat & Control

  • Rapidly clears and
    prevents breakouts
  • Helps improve the
    appearance of scars
    associated with acne
  • Kills 99.8% of acne
    causing bacteria

Contains 0.5% ethanol w/w

Net Wt 2 oz (56g)

PRINCIPAL DISPLAY PANEL - 56g Bottle Carton
PRINCIPAL DISPLAY PANEL - 56g Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43251-3333-62019-11-27C16284748780-19855d018-e174-cd31-e053-dbdaa90ab51anatralia™ NATURALLY AUSTRALIAN acne cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43251-3333-6Natralia Acne56 g in 1 BOTTLE, DISPENSINGCREAM563
43251-3333-6Natralia Acne1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43251-3333NATRALIA ACNE (CALENDULA OFFICINALIS FLOWER, CALCIUM CARBONATE, AND PULSATILLA VULGARIS) CREAM [LACORIUM HEALTH INTERNATIONAL PTY LTD]3Legacy NDC, 2 package rows20121222_bffc2c30-1b74-4475-997a-34debbcba696.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK3
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD3
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV3
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB3
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD3
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV3
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U3
Cetyl PalmitateINACTIVE INGREDIENT5ZA2S6B08X3
ChamomileINACTIVE INGREDIENTFGL3685T2X3
GlycerinINACTIVE INGREDIENTPDC6A3C0OX3
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE43
Lactic AcidINACTIVE INGREDIENT33X04XA5AT3
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T3
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4M3
Rosa Canina Fruit OilINACTIVE INGREDIENTCR7307M3QZ3
Sorbic AcidINACTIVE INGREDIENTX045WJ989B3
Sorbitan MonopalmitateINACTIVE INGREDIENT77K6Z421KU3
Sorbitan OlivateINACTIVE INGREDIENTMDL271E3GR3
SqualaneINACTIVE INGREDIENTGW89575KF93
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP3
Tea Tree OilINACTIVE INGREDIENTVIF565UC2G3
Witch HazelINACTIVE INGREDIENT101I4J0U343
Zinc PidolateINACTIVE INGREDIENTC32PQ86DH43

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43251-333343251-3333-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
ChamomileFGL3685T2XIACT
GlycerinPDC6A3C0OXIACT
Glyceryl Monostearate230OU9XXE4IACT
Lactic Acid33X04XA5ATIACT
Zinc PidolateC32PQ86DH4IACT
Cetyl Palmitate5ZA2S6B08XIACT
Sorbitan Monopalmitate77K6Z421KUIACT
Sorbitan OlivateMDL271E3GRIACT
Caprylyl Glycol00YIU5438UIACT
Sorbic AcidX045WJ989BIACT
PhenoxyethanolHIE492ZZ3TIACT
SqualaneGW89575KF9IACT
Polysorbate 60CAL22UVI4MIACT
Stearic Acid4ELV7Z65APIACT
Rosa Canina Fruit OilCR7307M3QZIACT
Tea Tree OilVIF565UC2GIACT
Witch Hazel101I4J0U34IACT

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 4 · 191 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Lactic AcidLACTIC ACID33X04XA5ATGEL / TOPICAL30 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SqualaneSQUALANEGW89575KF9POWDER / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
Cetyl PalmitateCETYL PALMITATE5ZA2S6B08XOINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
Sorbitan MonopalmitateSORBITAN MONOPALMITATE77K6Z421KULOTION / TOPICAL20 mgExact identifier — unii candidate
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCONCENTRATE / ORAL50 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MEMULSION / ORAL20 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCREAM / TOPICAL1 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Polysorbate 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CREAM / VAGINAL140 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BCONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
Sorbitan MonopalmitateSORBITAN MONOPALMITATE77K6Z421KUSYSTEM / TOPICAL10.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BTABLET / SUBLINGUAL0.16 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATINJECTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 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
b6a21ed9-7bb4-4fc5-b9be-d4b16eabe1fdbffc2c30-1b74-4475-997a-34debbcba6962012-12-19WarningsExact identifier
spl id: b6a21ed9-7bb4-4fc5-b9be-d4b16eabe1fd
spl set id: bffc2c30-1b74-4475-997a-34debbcba696

Reported adverse events (FAERS/openFDA)#

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