FDA.reportPublic FDA data

Grahams Natural Diaper Rash

Manufacturer
Grahams Natural Alternatives Pty Ltd
Effective date
2016-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:58

Label at a glance#

ProductGrahams Natural Diaper Rash
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

Zinc Oxide 12%

OTC - PURPOSE SECTION

PURPOSE

Skin Protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Uses and Indications

For the relief of diaper rash, minor cuts and burns

DOSAGE & ADMINISTRATION SECTION

Directions

Apply cream, liberally, and as often as necessary to dry skin, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

WARNINGS SECTION

Warnings 

For external use only

Avoider contact with eyes. If any adverse reaction develops, stop use, and contact a physician.

OTC - QUESTIONS SECTION



Questions 

www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Crt, Nerang, QLD 4211 Australia

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Purified Water, Betaine,
Glycerin, Cetearyl Alcohol, Glyceryl Stearate SE, Coco-
Caprylate, Prunus Amygdalus Dulcis (Sweet Almond) Oil),
Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum
Parkii (Shea Butter), Beeswax, Caprylic/Capric
Triglyceride, Sodium Stearoyl Glutamate, Jojoba Oil,
Xanthan Gum, Chamomile Extract, Calendula Extract,
Tocopherol Acetate, Phenoxyethanol, Capryl Glycol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back labelback labelFront LabelFront Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417994zinc oxide 12 % Topical CreamPSN1
417994zinc oxide 120 MG/ML Topical CreamSCD1
417994zinc oxide 12 % Topical CreamSY1
417994ZNO 120 MG/ML Topical CreamSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-139332996000469GTIN-13: 9332996000469
EAN-13: 9332996000469
GTIN storage (14 digits): 09332996000469		Diaper Rash Label -back label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42387-135-012020-01-31C16284748780-19d75b9d1-2787-f424-e053-dadaa90a57ce382b2771-99a4-5863-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42387-135-01Grahams Natural Diaper Rash73 g in 1 TUBECREAM731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42387-135GRAHAMS NATURAL DIAPER RASH (ZINC OXIDE) CREAM [GRAHAMS NATURAL ALTERNATIVES PTY LTD]1Legacy NDC, 1 package rows20160830_382b2771-99a4-5863-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42387-13542387-135-01

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
JOJOBA OIL724GKU717MIACT
CHAMOMILEFGL3685T2XIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
COCO-CAPRYLATE4828G836N6IACT
ALMOND OIL66YXD4DKO9IACT
SUNFLOWER OIL3W1JG795YIIACT
SHEA BUTTERK49155WL9YIACT
ZINC OXIDESOI2LOH54ZACTIB
XANTHAN GUMTTV12P4NEEIACT
CALENDULA ARVENSIS LEAF3U3U118F2LIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SODIUM LEVULINATEVK44E1MQU8IACT

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
382b84d8-6c03-24ca-e054-00144ff88e88382b2771-99a4-5863-e054-00144ff8d46c2016-08-30WarningsExact identifier
spl id: 382b84d8-6c03-24ca-e054-00144ff88e88
spl set id: 382b2771-99a4-5863-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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