FDA.reportPublic FDA data

Hygiene Clean Bubble Gum Hand Sanitizer

Manufacturer
USA Broom LLC
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:17

Label at a glance#

ProductHygiene Clean Bubble Gum 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 briskly until dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

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 avoid

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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 briskly until dry

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water; Propylene Glycol; Lauramine Oxide; Undeceth-7; Disodium EDTA; Aloe Barbadensis Gel; Glycereth-2-Cocoate; DMDM Hydantoin; Fragrance, Citric Acid

Package Labeling:50ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle9Bottle9

Package Labeling:50ml 24 bottles

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle10Bottle10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN3
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD3
1049254benzalkonium chloride 0.13 % Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80499-012-01Hygiene Clean Bubble Gum Hand Sanitizer50 mL in 1 BOTTLELIQUID503
80499-012-02Hygiene Clean Bubble Gum Hand Sanitizer50 mL in 1 BOTTLELIQUID503
80499-012-02Hygiene Clean Bubble Gum Hand Sanitizer24 in 1 BOXLIQUID243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80499-012HYGIENE CLEAN BUBBLE GUM HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [USA BROOM LLC]3Current NDC, Legacy NDC, 3 package rows20231030_b569875e-7a3d-17db-e053-2a95a90a3c2b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80499-01280499-012-01, 80499-012-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LAURAMINE OXIDE4F6FC4MI8WIACT
UNDECETH-7R6B5PCO2JNIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
DMDM HYDANTOINBYR0546TOWIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
Hygiene Clean Bubble Gum Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb569875e-7a3d-17db-e053-2a95a90a3c2b2023-10-28WarningsExact identifier
ndc (package): 80499-012-01
ndc (package): 80499-012-02
ndc (product): 80499-012
ndc11 (package): 80499001202
ndc11 (package): 80499001201
spl id: 08c019c9-2ced-8867-e063-6294a90a5182
spl set id: b569875e-7a3d-17db-e053-2a95a90a3c2b

Reported adverse events (FAERS/openFDA)#

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