FDA.reportPublic FDA data

DERMADIVE ULTRACARE - TETRAID

Manufacturer
Releaf Technologies LLC
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:43

Label at a glance#

ProductDERMADIVE ULTRACARE - TETRAID
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

TO PROTECT SKIN AND SPEED HEALING OF WOUNDS AND SORES.

Dosage and administration

APPLY AS NEEDED TO AFFECTED AREAS.

Storage and handling

PROTECT PRODUCT FROM EXCESSIVE MOISTURE - AVOID STORING IN DIRECT SUNLIGHT - STORE WITH LID TIGHTLY CLOSED.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

OTC - PURPOSE SECTION

ANTIMICROBIAL

USES

INDICATIONS & USAGE SECTION

TO PROTECT SKIN AND SPEED HEALING OF WOUNDS AND SORES.

WARNING

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

DO NOT USE ON DEEP PUNCTURE WOUNDS OR LACERATIONS.

WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES.

STOP USING AND ASK A DOCTOR IF

  • THE CONDITION WORSENS
  • A RASH OR IRRITATION DEVELOPS.

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 TO AFFECTED AREAS.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

PROTECT PRODUCT FROM EXCESSIVE MOISTURE - AVOID STORING IN DIRECT SUNLIGHT - STORE WITH LID TIGHTLY CLOSED.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

PURIFIED WATER, GLYCERYL STEARATE, EMULSIFYING WAX, STEARYL ALCOHOL, CETYL ALCOHOL, CYCLOTETRASILOXANE (AND) CYCLOPENTASILOXANE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, ETHOXYDIGLYCOL, PROPYLENE GLYCOL, WATER, LECITHIN, ALCOHOL, GLYCERIN, TEA TREE OIL, TRIETHANOLAMINE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Tetraid_100mL01b LBL_Tetraid_100mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046442benzalkonium chloride 0.13 % Topical LotionPSN3
1046442benzalkonium chloride 1.3 MG/ML Topical LotionSCD3
1046442benzalkonium chloride 0.13 % Topical LotionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78663-102-34DERMADIVE ULTRACARE - TETRAID100 mL in 1 TUBELOTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78663-102DERMADIVE ULTRACARE - TETRAID (BENZALKONIUM CHLORIDE) LOTION [RELEAF TECHNOLOGIES LLC]3Current NDC, 1 package rows20250112_025c0b33-73ca-334b-e063-6394a90ad668.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78663-10278663-102-34

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
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
POLYSORBATE 60CAL22UVI4MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TROLAMINE9O3K93S3TKIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CYCLOMETHICONE 4CZ227117JEIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETYL ALCOHOL936JST6JCNIACT
TEA TREE OILVIF565UC2GIACT
ALCOHOL3K9958V90MIACT
CYCLOMETHICONE 50THT5PCI0RIACT

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
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
ndc (package): 78663-102-34
ndc (product): 78663-102
ndc11 (package): 78663010234
spl id: 2b47af26-00c4-5628-e063-6294a90ad70b
spl set id: 025c0b33-73ca-334b-e063-6394a90ad668

Reported adverse events (FAERS/openFDA)#

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