FDA.reportPublic FDA data

Natralia™ Happy Little Bodies™ Eczema Relief Cream

Manufacturer
LaCorium Health USA Inc. | Ross cosmetics Pty ltd
Effective date
2020-12-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:00:58

Label at a glance#

ProductNatralia Happy Little Bodies Eczema Relief
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites

Dosage and administration

Apply as needed Smooth in gently

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes
  • eczema
  • poison ivy, oak, or sumac
  • insect bites

Warnings

WARNINGS SECTION

For external use only.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • If contact occurs, rinse eyes thoroughly with water. Apply a small amount to healthy skin
  • wait 15 minutes. If redness or swelling occurs, discontinue use.
  • Do not use on broken skin.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed
  • Smooth in gently

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Benzyl Alcohol, Calendula Tincture, Castor Oil, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Citric Acid, Dehydroxanthan Gum, Glycerine, Peppermint Oil, Phenoxyethanol, Shea Nut Butter, Sodium Hydroxide, Water, Zinc Oxide

Questions or Comments?

OTC - QUESTIONS SECTION

Call Toll Free 1-877-687-2542
usainfo@natralia.com

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW
LOOK!
Same gentle formula

NDC 43251-0864-1

natralia™
NATURALLY AUSTRALIAN

happy
little
bodies™

ECZEMA
RELIEF
CREAM

SOOTHES
RASHES &
FLARE UPS

SKIN PROTECTANT
GENTLE FORMULA
CORTISONE FREE

Net Wt
2 oz (56g)

Principal Display Panel - 56 g Tube Carton
Principal Display Panel - 56 g Tube Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663Y1
OATMEALACTIVE MOIETY8PI54V663Y1
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
Benzyl alcoholINACTIVE INGREDIENTLKG8494WBH1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
Castor oilINACTIVE INGREDIENTD5340Y2I9G1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNA1
Cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1S1
Cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
DEHYDROXANTHAN GUMINACTIVE INGREDIENT63ZP7I1BQO1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Shea butterINACTIVE INGREDIENTK49155WL9Y1
Sodium hydroxideINACTIVE INGREDIENT55X04QC32I1
WaterINACTIVE INGREDIENT059QF0KO0R1
Zinc oxideINACTIVE INGREDIENTSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43251-086443251-0864-1, 43251-0864-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
Water059QF0KO0RIACT
Aloe Vera LeafZY81Z83H0XIACT
PEPPERMINT OILAV092KU4JHIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
GlycerinPDC6A3C0OXIACT
Shea butterK49155WL9YIACT
Cetostearyl alcohol2DMT128M1SIACT
Castor oilD5340Y2I9GIACT
Zinc oxideSOI2LOH54ZIACT
Benzyl alcoholLKG8494WBHIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
PhenoxyethanolHIE492ZZ3TIACT
Sodium hydroxide55X04QC32IIACT
Cetyl alcohol936JST6JCNIACT

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 8 · 439 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCONJUNCTIVAL252 mgExact identifier — unii candidate
50 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / PERIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Benzyl alcoholBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
50 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / OPHTHALMIC0.09 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
Benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IDISC / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Castor oilCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / SUBCUTANEOUS25 mgExact identifier — unii candidate
61 equally ranked IID candidates
Benzyl alcoholBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
Castor oilCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / SOFT TISSUE40 mgExact identifier — unii candidate
50 equally ranked IID candidates
Castor oilCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / EXTRACORPOREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Benzyl alcoholBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
61 equally ranked IID candidates
Cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 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
446b1216-99ad-4940-b62c-bd32eb70f7edea95e097-34e4-4dbd-9751-3111f4f27eed2020-12-15WarningsExact identifier
spl id: 446b1216-99ad-4940-b62c-bd32eb70f7ed
spl set id: ea95e097-34e4-4dbd-9751-3111f4f27eed

Reported adverse events (FAERS/openFDA)#

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