FDA.reportPublic FDA data

TriDerma Stubborn Diaper Rash Cream

Manufacturer
Genuine Virgin Aloe Corporation
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:50

Label at a glance#

ProductTriDerma Stubborn Diaper Rash Relief
Active ingredientALLANTOIN
Label structure9 sections

Storage and handling

Store at room temperature for use on infants or children

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

diaper carton 168.jpgdiaper carton 168.jpgdiaper label 168diaper label 168

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 1.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects and helps relieve chafed, chapped or cracked skin

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on

  • deep or puncture wounds
  • on infections
  • on lacerations

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

if condition worsens or does not improve within 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - QUESTIONS SECTION

Questions: 1-800-279-7282 M-F 8 am-4pm PST

STORAGE AND HANDLING SECTION

  • Store at room temperature
  • for use on infants or children

INACTIVE INGREDIENT SECTION


Aloe Barbadensis Leaf Juice*,
Avena Sativa (Oat) Kernel Flour, Cera Alba (Beeswax),
Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cetyl
Alcohol, Dimethicone, Ethylhexylglycerin, Glyceryl Stearate,
Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed
Oil, Isopropyl Palmitate, Panthenol (Pro-Vitamin B5),
Phenoxyethanol, Polysorbate 60, Potassium Cetyl
Phosphate, Propanediol, Sodium Hyaluronate, Sodium
Hydroxide, Sodium PCA, Sodium Phytate, Tocopheryl
Acetate (Vitamin E), Water (Aqua), Xanthan Gum, Zinc PCA.

DOSAGE & ADMINISTRATION SECTION

Change wet/soiled diapers promptly. Cleanse diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

diaper cartondiaper cartondiaper labeldiaper label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130818926010566GTIN-13: 0818926010566
EAN-13: 0818926010566
GTIN-12: 818926010566
UPC-A: 818926010566
GTIN storage (14 digits): 00818926010566		diaper carton 168.jpg, diaper label 168.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10738-168-40TriDerma Stubborn Diaper Rash Relief1 in 1 CARTONCREAM11
10738-168-45TriDerma Stubborn Diaper Rash Relief113 g in 1 TUBECREAM1131

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10738-16810738-168-45, 10738-168-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
SODIUM PCA469OTG57A2IACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
SODIUM PHYTATE88496G1ERLIACT
BEESWAX2ZA36H0S2VIACT
CETYL ALCOHOL936JST6JCNIACT
PANTHENOLWV9CM0O67ZIACT
GLYCERYL STEARATE230OU9XXE4IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ALLANTOIN344S277G0ZACTIB
CETEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
AVENA SATIVA (OAT) STARCH904CE6697VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
DIMETHICONE 100RO266O364UIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPANEDIOL5965N8W85TIACT
ZINC PCAC32PQ86DH4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYALURONATEYSE9PPT4THIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
TriDerma Stubborn Diaper Rash ReliefALLANTOIN CREAMGenuine Virgin Aloe Corporation497606cd-5b58-9249-e063-6394a90ae3212026-01-28WarningsExact identifier
ndc (package): 10738-168-45
ndc (package): 10738-168-40
ndc (product): 10738-168
ndc11 (package): 10738016840
ndc11 (package): 10738016845
spl id: 497606cd-5b59-9249-e063-6394a90ae321
spl set id: 497606cd-5b58-9249-e063-6394a90ae321

Reported adverse events (FAERS/openFDA)#

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