FDA.reportPublic FDA data

Diaper Rash Cream

Manufacturer
Smalls Brand LLC DBA Roe Wellness
Effective date
2026-02-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:44

Label at a glance#

ProductDiaper Rash Cream
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients:

Zinc Oxide 15% Purpose Skin protectant

OTC - PURPOSE SECTION

Uses: Helps prevent irritation

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warning:

  • For external use only. When using this product keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION SECTION

Directions: After changing diaper allow the area to dry. then apply diaper rash cream liberally to affected areas.

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Glycerin. C13-15 Alkane, Ethylhexyl Olivate, Propanediol, Polyglyceryl-3 Polyricinoleate, Bis-Octyldodecylhexyl Dimer Dilinoleate/Propanediol Copolymer, Cocoglycerides, Meadowfoam Estolide, Disteardimonium Hectorite, Jojoba Esters, Hydrogenated Castor Oil, Lactococcus Ferment Lysate, Rhus Verniciflua Peel Wax, Squalane, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Linoleic Acid, Betaine, Sucrose, Hydroxyacetophenone, Phospholipids, Phytosterols, Sodium Citrate, Hydrolyzed Rhodophyceae Extract, Bisabolol, Panthenol, Sodium Dehydroacetate, Stearyl Glycyrrhetinate, Tocopherol, Tetrasodium Glutamate Diacetate, Linolenic Acid, Avena Sativa (Oat) Kernel Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diaper Rash Cream

alleviate + soothe

Net Wt oz 85g

Daper Rash CreamDaper Rash Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245660zinc oxide 15 % Topical CreamPSN1
245660zinc oxide 150 MG/ML Topical CreamSCD1
245660zinc oxide 15 % Topical CreamSY1
245660ZNO 150 MG/ML Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83369-002-01Diaper Rash Cream85 g in 1 CARTONCREAM851

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83369-00283369-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
C13-15 ALKANE114P5I43UJIACT
ETHYLHEXYL OLIVATEHTC7G3S2PVIACT
PANTHENOLWV9CM0O67ZIACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
SQUALANEGW89575KF9IACT
CAPRYLYL GLYCOL00YIU5438UIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
WATER059QF0KO0RIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
OMEGA-3 FATTY ACIDS71M78END5SIACT
PYRUS MALUS (APPLE) FRUITB423VGH5S9IACT
SODIUM DEHYDROACETATE8W46YN971GIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
LINOLENIC ACID0RBV727H71IACT
LEVOMENOL24WE03BX2TIACT
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMERTY3J98ZR7RIACT
COCO-GLYCERIDESISE9I7DNUGIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ZINC OXIDESOI2LOH54ZACTIB
PROPANEDIOL5965N8W85TIACT
MEADOWFOAM ESTOLIDE3HH93SL2H9IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
RHUS VERNICIFLUA PEEL WAX6RG2461FCHIACT
GLYCERINPDC6A3C0OXIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
TOCOPHEROLR0ZB2556P8IACT
OATZ6J799EAJKIACT
SHEA BUTTERK49155WL9YIACT
BETAINE3SCV180C9WIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
SUCROSEC151H8M554IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LINOLEIC ACID9KJL21T0QJIACT

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
Diaper Rash CreamZINC OXIDESmalls Brand LLC DBA Roe Wellness4bd29285-29b4-5d57-e063-6294a90af4812026-02-27WarningsExact identifier
ndc (package): 83369-002-01
ndc (product): 83369-002
ndc11 (package): 83369000201
spl id: 4bd29285-29b5-5d57-e063-6294a90af481
spl set id: 4bd29285-29b4-5d57-e063-6294a90af481

Reported adverse events (FAERS/openFDA)#

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