FDA.reportPublic FDA data

Circle B manufacturing foaming alcohol free Hand sanitizer

Manufacturer
Circle B Manufacturing, Inc.
Effective date
2021-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:39

Label at a glance#

ProductCircle B manufacturing foaming alcohol free Hand sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

- For hand sanitizing to decrease the bacteria on skin. - Recommended for repeated use

Dosage and administration

- Pump a small amount of foam into palm of hand - Rub thoroughly over all surfaces of both hands - Rub hands together to produce a thick lather

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

- For hand sanitizing to decrease the bacteria on skin.
- Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or redness develops, or if condition persists for more than 72 hours.

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

- Pump a small amount of foam into palm of hand
- Rub thoroughly over all surfaces of both hands
- Rub hands together to produce a thick lather

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Lauramine Oxide, Undeceth-7, Disodium EDTA, DMDM Hydantoin, Fragrance, Citric Acid, FD&C Red #33, FD&C Blue #1.

Package Labeling:3790ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN1
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD1
1038799benzalkonium chloride 0.1 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81458-000-012023-01-30C16284748780-1f386c649-d9bc-0266-e053-dadaa90a7c1aCircle B manufacturing foaming alcohol free Hand sanitizer
81458-000-022023-01-30C16284748780-1f386c649-d9bc-0266-e053-dadaa90a7c1aCircle B manufacturing foaming alcohol free Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81458-000-01Circle B manufacturing foaming alcohol free Hand sanitizer3790 mL in 1 BOTTLELIQUID37901
81458-000-02Circle B manufacturing foaming alcohol free Hand sanitizer3790 mL in 1 BOTTLELIQUID37901
81458-000-02Circle B manufacturing foaming alcohol free Hand sanitizer4 in 1 PACKAGELIQUID41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81458-000CIRCLE B MANUFACTURING FOAMING ALCOHOL FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [CIRCLE B MANUFACTURING, INC.]1Legacy NDC, 3 package rows20210202_ba47353a-5c17-07f2-e053-2995a90aa24f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81458-00081458-000-01, 81458-000-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
UNDECETH-7R6B5PCO2JNIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DMDM HYDANTOINBYR0546TOWIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
ba47353a-5c18-07f2-e053-2995a90aa24fba47353a-5c17-07f2-e053-2995a90aa24f2021-02-01WarningsExact identifier
spl id: ba47353a-5c18-07f2-e053-2995a90aa24f
spl set id: ba47353a-5c17-07f2-e053-2995a90aa24f

Reported adverse events (FAERS/openFDA)#

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