FDA.reportPublic FDA data

TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER

Manufacturer
Genuine Virgin Aloe Corporation
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:35:23

Label at a glance#

ProductTRIDERMA PROTECT AND HEAL NON- GREASY BARRIER
Active ingredientALLANTOIN, DIMETHICONE
Label structure12 sections

Storage and handling

Other information  • store at room temperature • use on infants, children or adults

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 1.5%

Dimethicone 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Uses •helps treat and prevent diaper rash. Protects chafed skin/minor skin irritation due to/associated with diaper rash •helps protect from/seal out wetness •temporarily protect and helps relieve chafed, chapped, or cracked skin

WARNINGS SECTION

Warnings For external use only. Do not use •on deep puncture wounds •on infections •on lacerations. When using this product •do not get into eyes Stop use and ask a doctor if •condition worsens or does not improve within 7 days. 

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.

DOSAGE & ADMINISTRATION SECTION

Directions •gently clean the irritated area before use. Then apply a generous layer of cream. It can be left on thick or rubbed into skin. Use as many times a day as necessary until healed. For continuous protection and healthy skin, use daily or as needed.

STORAGE AND HANDLING SECTION

Other information •store at room temperature •use on infants, children or adults

INACTIVE INGREDIENT SECTION

Inactive ingredients: water, butyrospermum parkii (shea) butter, glycerin, glyceryl stearate SE, cera alba (beeswax), cetearyl alcohol, carthamus tinctorius (safflower) seed oil, avena sativa (oat) kernel flour, aloe barbadensis leaf juice*, polysorbate 60, polysorbate 80, cetyl esters, zinc PCA, sodium PCA, panthenol (pro-vitamin B-5), tocopheryl acetate (vitamin E), glyceryl stearate, silica, sodium hyaluronate, sodium phytate, potassium cetyl phosphate, xanthan gum, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.*Certified Organic Ingredient - Mayacert Certifier

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

AP4 ® BOTANICAL

ALOE VERA COMPLEX

Allantoin & Dimenthicone

Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 Made in USA 

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

oneone

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

twotwo

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

threethree

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1927024allantoin 1.5 % / dimethicone 2 % Topical CreamPSN5
1927024allantoin 15 MG/ML / dimethicone 20 MG/ML Topical CreamSCD5
1927024allantoin 1.5 % / dimethicone 2 % Topical CreamSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10738-061-452023-02-02C16284748780-1f386c649-ac71-0266-e053-dadaa90a7c1aTRIDERMA Protect & Heal Non-Greasy Barrier
10738-061-502023-02-02C16284748780-1f386c649-ac71-0266-e053-dadaa90a7c1aTRIDERMA Protect & Heal Non-Greasy Barrier
10738-061-452023-01-30C16284748780-1f386c649-ac71-0266-e053-dadaa90a7c1aTRIDERMA Protect & Heal Non-Greasy Barrier
10738-061-502023-01-30C16284748780-1f386c649-ac71-0266-e053-dadaa90a7c1aTRIDERMA Protect & Heal Non-Greasy Barrier

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10738-061-45TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER113 g in 1 TUBECREAM1135
10738-061-50TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER1 in 1 CARTONCREAM15
10738-061-55TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER14 g in 1 TUBECREAM145

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10738-06110738-061-45, 10738-061-55, 10738-061-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
YELLOW WAX2ZA36H0S2VIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SAFFLOWER OIL65UEH262ISIACT
OATMEAL8PI54V663YIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 60CAL22UVI4MIACT
POLYSORBATE 806OZP39ZG8HIACT
CETYL ESTERS WAXD072FFP9GUIACT
ZINC PIDOLATEC32PQ86DH4IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
PHYTATE SODIUM88496G1ERLIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALLANTOIN344S277G0ZACTIB
DIMETHICONE92RU3N3Y1OACTIB

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 PROTECT AND HEAL NON- GREASY BARRIERALLANTOIN, DIMETHICONEGenuine Virgin Aloe Corporation3209f075-90bf-4141-b5f3-8175c1ee6ba02026-01-28WarningsExact identifier
ndc (package): 10738-061-55
ndc (package): 10738-061-45
ndc (package): 10738-061-50
ndc (product): 10738-061
ndc11 (package): 10738006145
ndc11 (package): 10738006155
ndc11 (package): 10738006150
spl id: 497d0bdf-c6b3-df5b-e063-6294a90a0314
spl set id: 3209f075-90bf-4141-b5f3-8175c1ee6ba0

Reported adverse events (FAERS/openFDA)#

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