FDA.reportPublic FDA data

Reddot Hand Sanitizer

Manufacturer
A J S & Associates, Inc
Effective date
2021-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:42

Label at a glance#

ProductReddot Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Receive appropriate amount of sanitizer to palm of hand. Rub thoroughly over all surfaces of both hands. Continue to rub hands together until dry.

Label contents#

Full prescribing information#

Directions

DOSAGE & ADMINISTRATION SECTION

  • Receive appropriate amount of sanitizer to palm of hand.
  • Rub thoroughly over all surfaces of both hands.
  • Continue to rub hands together until dry.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Eye irritant. In case of contact, immediately flush eyes for 15 minutes. If irritation persists, get medical attention. Harmful if swallowed.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1% . . . . . . . . . Antimicrobial

Use

INDICATIONS & USAGE SECTION

Recommended for repeated use

Purpose

OTC - PURPOSE SECTION

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product:

  • Avoid contact with eyes. In case of eye contact, flush eyes with water
  • Stop use and ask a doctor if irritation or redness develops, and if condition persists for more than 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical attention or contact poison control right away

Directions

OTC - WHEN USING SECTION

  • Pump a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, cocoamidopropyl PG-dimonium chloride phosphate, dihydroxyethyl cocamine oxide, acetamidoethoxyethanol, citric acid

Questions

OTC - QUESTIONS SECTION

Contact RedDot Brands Mon-Fri 9am-5pm EST at 608-524-4341

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REORDER: DC7000

Manufactured for:

Hankscraft, Inc./ dba RedDot Brands

300 Wengel Drive

Reedsburg, WI 53959

608-524-4341

www.reddotbrands.com

Foaming Non-Alcohol Hand Sanitizer

with Benzalkonium Chloride

Alcohol-Free

Foaming

Hand Sanitizer

reddot

Net Contents: 1000 mL NDC: 80821-028-01

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN2
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD2
1038799benzalkonium chloride 0.1 % Topical FoamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80821-028-012022-07-29C16284748780-1e4f33bdf-ab0c-d8a0-e053-dadaa90a6e4eb1081a6c-48f0-9ccd-e053-2a95a90ac1fb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80821-028-01Reddot Hand Sanitizer1000 mL in 1 BAGLIQUID10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80821-028REDDOT HAND SANITIZER (HAND SANITIZER) LIQUID [A J S & ASSOCIATES, INC]2Legacy NDC, 1 package rows20211217_b1081a6c-48f0-9ccd-e053-2a95a90ac1fb.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80821-02880821-028-01
78245-200

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
ACETAMIDOETHOXYETHANOLLVX2APC4XRIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
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
d346b6e4-4fd1-2619-e053-2995a90a0543b1081a6c-48f0-9ccd-e053-2a95a90ac1fb2021-12-16WarningsExact identifier
spl id: d346b6e4-4fd1-2619-e053-2995a90a0543
spl set id: b1081a6c-48f0-9ccd-e053-2a95a90ac1fb

Reported adverse events (FAERS/openFDA)#

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