FDA.reportPublic FDA data

Dermaleve

Manufacturer
Advanced Derm Solutions LLC
Effective date
2023-02-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:38:18

Label at a glance#

ProductDermaleve
Active ingredientALUMINUM ACETATE
Label structure9 sections

Indications and uses

• Insects Bites • Minor Burn • Athlete's foot  • Poison lvy  • Poison oak • Poison sumac  • Rashes cause by soaps, detergents, cosmetic or jewelry

Dosage and administration

Adults and children two years of age and older, apply to affected area as needed or as directed by a doctor. Consult a doctor for children under the age of two.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Aluminum acetate (0.2%)

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

• Insects Bites
• Minor Burn
• Athlete's foot 
• Poison lvy 
• Poison oak
• Poison sumac 
• Rashes cause by soaps, detergents, cosmetic or jewelry

Warnings

WARNINGS SECTION

■ For external use only.
■ Avoid contact with eyes.
■ Do not apply to open wounds.
■ STOP USE and ask a doctor if condition worsens
or symptoms persist for more than seven days.

■ Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children two years of age and older,
apply to affected area as needed or as directed by a doctor. Consult a doctor for children under the age of two.

Inactive ingredients 

INACTIVE INGREDIENT SECTION

Water, Strontium Nitrate, Isopropyl Myristate, Butyrospermum Parkii (shea) Butter, Caprylyc/Capric Triglyceride, Cetearyl Alcohol, Emulsifying Wax NF, Glycerin, Phenoxyethanol, Magnesium Aluminum Silicate, Glyceryl Stearate, Dimethicone, Polyacrylate Crosspolymer-6, Xanthan Gum, Caprylyl Glycol, Sodium Hyaluronate, Disodium EDTA, Ceramide NG, Tocopherol (Vitamin E), Tetrahexyldecyl Ascorbate

SPL UNCLASSIFIED SECTION

Manufactured for Advanced Derm Solutions LLC
Ocala, FL 34472 | dermaleve.com
U.S. Patents: 5,716,625; 5,804,203; 6,139,850; 7,404,967

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81507-001-012023-02-03C16284748780-1f386c649-a48d-0266-e053-dadaa90a7c1aa4148bd7-ef15-47f0-96f5-0c80d9b1b2c6
81507-001-022023-02-03C16284748780-1f386c649-a48d-0266-e053-dadaa90a7c1aa4148bd7-ef15-47f0-96f5-0c80d9b1b2c6
81507-001-032023-02-03C16284748780-1f386c649-a48d-0266-e053-dadaa90a7c1aa4148bd7-ef15-47f0-96f5-0c80d9b1b2c6
81507-001-012023-01-30C16284748780-1f386c649-a48d-0266-e053-dadaa90a7c1aa4148bd7-ef15-47f0-96f5-0c80d9b1b2c6
81507-001-022023-01-30C16284748780-1f386c649-a48d-0266-e053-dadaa90a7c1aa4148bd7-ef15-47f0-96f5-0c80d9b1b2c6
81507-001-032023-01-30C16284748780-1f386c649-a48d-0266-e053-dadaa90a7c1aa4148bd7-ef15-47f0-96f5-0c80d9b1b2c6

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81507-00181507-001-01, 81507-001-02, 81507-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
CERAMIDE NGC04977SRJ5IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE 100RO266O364UIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MAGNESIUM ALUMINUM SILICATE TYPE IASUS08ZOA9SIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLAWAX POLYSORBATEQ504PL8E0VIACT
SHEA BUTTERK49155WL9YIACT
STRONTIUM NITRATEBDG873AQZLIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TOCOPHEROLR0ZB2556P8IACT
WATER O-187QV8F8BYNJIACT
XANTHAN GUMTTV12P4NEEIACT
ALUMINUM ACETATE80EHD8I43DACTIB

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
f3cdae5b-7945-1bf1-e053-2995a90aff56a4148bd7-ef15-47f0-96f5-0c80d9b1b2c62023-02-03WarningsExact identifier
spl id: f3cdae5b-7945-1bf1-e053-2995a90aff56
spl set id: a4148bd7-ef15-47f0-96f5-0c80d9b1b2c6

Reported adverse events (FAERS/openFDA)#

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