FDA.reportPublic FDA data

DermaCen Lotionized Hand Sanitizer

Manufacturer
Central Solutions Inc | Central Solutions
Effective date
2024-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:54

Label at a glance#

ProductDermaCen Lotionized Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

An effective antimicrobial hand cleanser for topical application Recommended for repeated use Reduces transient microorganisms on intact skin Keeps hands from drying out due to repeated uses

Dosage and administration

Wet hands thoroughly with product. Allow to dry without wiping. Use no water or towels

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • An effective antimicrobial hand cleanser for topical application
  • Recommended for repeated use
  • Reduces transient microorganisms on intact skin
  • Keeps hands from drying out due to repeated uses

Warnings

WARNINGS SECTION

  • For External Use Only.
  • Flammable, keep away from fire or open flame

OTC - WHEN USING SECTION

When using this product:

  • Avoid contact with eyes
  • In case of eye contact, flush with water for 15 nibutes
  • Discontinue use and see a doctor if irritation occurs
  • Avoid contact with broken skin

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product. Allow to dry without wiping. Use no water or towels

Other information

OTHER SAFETY INFORMATION

  • Not tested on animals

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Cetyl Alcohol, Fragrance, Glycerin, Glyceryl Laurate, Hydroxypropyl Cellulose, Isopropyl Myristate, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C),Sodium Starch Octenylsuccinate, Titanium Dioxide, Tocopherol (Vitamin E), Tocopheryl Acetate (Vitamin E), Trehalose, Water

Questions?

OTC - QUESTIONS SECTION

Call 800-255-0262

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 62654-151-64

DermaCen

Lotionized

Hand

Sanitizer

For hand washing

to decrease bacteria

on the skin

Net Contents:

8 oz (236mL)

container labelDCLHScontainer labelDCLHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1809903ethanol 70 % Topical LotionPSN1
1809903ethanol 0.7 ML/ML Topical LotionSCD1
1809903ethanol 70 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62654-151-64DermaCen Lotionized Hand Sanitizer236 mL in 1 BOTTLELIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62654-151DERMACEN LOTIONIZED HAND SANITIZER (ALCOHOL) LIQUID [CENTRAL SOLUTIONS INC]1Current NDC, 1 package rows20240809_1f1e6c95-533f-d3e4-e063-6394a90a0560.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62654-15162654-151-64

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TOCOPHEROLR0ZB2556P8IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETYL ALCOHOL936JST6JCNIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
OCTENYLSUCCINIC ACID12UZE4X73LIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
TREHALOSEB8WCK70T7IIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
NIACINAMIDE25X51I8RD4IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT

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
DermaCen Lotionized Hand SanitizerALCOHOLCentral Solutions Inc1f1e6c95-533f-d3e4-e063-6394a90a05602024-08-07WarningsExact identifier
ndc (package): 62654-151-64
ndc (product): 62654-151
ndc11 (package): 62654015164
spl id: 1f1e6c95-5340-d3e4-e063-6394a90a0560
spl set id: 1f1e6c95-533f-d3e4-e063-6394a90a0560

Reported adverse events (FAERS/openFDA)#

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