FDA.reportPublic FDA data

Frozen Bubble Gum Hand Sanitizer

Manufacturer
shenzhen Lantern Science Co. Ltd.
Effective date
2016-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:16

Label at a glance#

ProductFrozen Bubble Gum Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzalkonium Chloride 0.01%



Purpose: Antibacterial

OTC - PURPOSE SECTION

Use

To decrease bacteria on the skin that could cause disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Frozen Bubble Gum Hand Sanitizer

2 FL OZ (59mL)

WARNINGS SECTION

Warnings

  • for external use only-hands.
  • keep out of eyes. avoid contact with broken skin.
  • stop use and ask a Doctor if irritation or redness develops.
  • do not inhale or ingest. if swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Rub a dime sized drop into hands.
  • For children under 6 use under adult supervision.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water (aqua/eau), coceth-7, PPG-1-PEG-9 lauryl glycol ether, triethanolamine, PEG-40 hydrogenated castor oil, chloropropylate, fragrance (parfum).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54860-033-012022-01-28C16284748780-1d6a99b39-6841-a426-e053-dadaa90af4c23530f86f-33ae-1d07-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54860-033-01Frozen Bubble Gum Hand Sanitizer59 g in 1 BOTTLEGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54860-033FROZEN BUBBLE GUM HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [SHENZHEN LANTERN SCIENCE CO. LTD.]1Legacy NDC, 1 package rows20160614_3530f86f-33ae-1d07-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54860-03354860-033-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCETH-7 CARBOXYLIC ACID35KO064932IACT
CHLOROPROPYLATEGI03ROM7HQIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
PPG-1-PEG-9 LAURYL GLYCOL ETHER5R8J43K25LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
D&C RED NO. 339DBA0SBB0LIACT

Source Document#

Source XML · Source PDF

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
3530f86f-33af-1d07-e054-00144ff8d46c3530f86f-33ae-1d07-e054-00144ff8d46c2016-06-13WarningsExact identifier
spl id: 3530f86f-33af-1d07-e054-00144ff8d46c
spl set id: 3530f86f-33ae-1d07-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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