FDA.reportPublic FDA data

DewMed Instant Antibacterial Cleansing Gel Hand Sanitizer

Manufacturer
DewMed LLC
Effective date
2020-09-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:47

Label at a glance#

ProductDewMed Instant Antibacterial Cleansing Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds.

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Polyquaternium-37, Glycerin, Panthenol, Niacinamide, Polysorbate 20, Tocopheryl Acetate, Pelargonium Graveolens (Rose Geranium) Flower Oil, Tagetes Minuta (Wild Marigold) Flower Extract, Rosa Damascena (Rose Otto) Flower Oil, Jasminum Officinale (Jasmine) Flower Extract, Citrus Aurantinum (Neroli) Flower Oil, Propylene Glycol, Benzyl Alcohol, Methlchloroisothiazolinone, Methylisothiazolinone, FD&C Blue 1.

Other information

SPL UNCLASSIFIED SECTION

Store between 15-30°C (59-86F).
Avoid freezing and excessive heat above 40°C (104F).

Questions or comments

OTC - QUESTIONS SECTION

1-877-847-0060  dewmedgroup@gmail.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottlebottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSN1
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCD1
1049228benzalkonium chloride 0.1 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80065-001-012022-01-28C16284748780-1d6a99b39-e26d-a426-e053-dadaa90af4c2DewMed Instant Antibacterial Cleansing Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80065-001-01DewMed Instant Antibacterial Cleansing Hand Sanitizer50 mL in 1 BOTTLEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80065-001DEWMED INSTANT ANTIBACTERIAL CLEANSING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [DEWMED LLC]1Legacy NDC, 1 package rows20200920_af87b1b7-65b3-0eaf-e053-2a95a90a10a0.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80065-00180065-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYQUATERNIUM-37 (10000 MPA.S)41QWS48DFNIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
NIACINAMIDE25X51I8RD4IACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
TAGETES MINUTA FLOWER OIL1T0ZMU8M8BIACT
ROSA X DAMASCENA FLOWER OIL18920M3T13IACT
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
CITRUS AURANTIUM FLOWER OILD4BGE91OXHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
af87df4e-2c96-e23e-e053-2a95a90ab354af87b1b7-65b3-0eaf-e053-2a95a90a10a02020-09-17WarningsExact identifier
spl id: af87df4e-2c96-e23e-e053-2a95a90ab354
spl set id: af87b1b7-65b3-0eaf-e053-2a95a90a10a0

Reported adverse events (FAERS/openFDA)#

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