FDA.reportPublic FDA data

Bubble Gum

Manufacturer
Brands Internation Corp | Brands International Corp
Effective date
2015-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:43

Label at a glance#

ProductBubble Gum
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient - Ethyl Alcohol 62%

OTC - PURPOSE SECTION

Purpose - Antiseptic

INDICATIONS & USAGE SECTION

Use

  • to decrease bacteria on the skin and clean hands
  • recommeded for repeated use

WARNINGS SECTION

Warnings

for external use only

Flammable, keep away from fire or flame

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of children. If accidently swallowed, get medical helpor contact a Poison Control Center right away

USER SAFETY WARNINGS SECTION

Do not get into eyes, If contact occurs, rinse thoroughly with water

OTC - ASK DOCTOR/PHARMACIST SECTION

Discontinue Use if irritation or redness develops, If irritation persists for more than 72 hours, consult a doctor

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply to hands until thoroughly wet
  • rub vigorously until dry
  • supervise children in the use of this product

USER SAFETY WARNINGS SECTION

Other information

  • may discolor certain fabrics or surfaces
  • do not store above 110 F (43 C)

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Prpanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Heilanthus Annuus) Seed Extract, Grapefruit (Citrus Grandis) Seed Extract, yellow 6 (Cl 15985) Red 40 (Cl 16035)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bubble Gum Antibacterial Hand Sanitizer GelBubble Gum Antibacterial Hand Sanitizer Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-116-012021-01-29C16284748780-1ba0f9c33-2c2b-a910-e053-dadaa90a0b853f8bfbc5-c5bf-1523-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-116-01Bubble Gum29 mL in 1 BOTTLEGEL291

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-116BUBBLE GUM (ANTIBACTERIAL HAND SANITIZER GEL) GEL [BRANDS INTERNATION CORP]1Legacy NDC, 1 package rows20161023_3f8bfbc5-c5bf-1523-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-11650157-116-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
ALCOHOL3K9958V90MACTIB
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
SUNFLOWER SEEDR9N3379M4ZIACT
GRAPEFRUIT SEED OIL598D944HOLIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
WATER059QF0KO0RIACT

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
3f8bfbc5-c5c0-1523-e054-00144ff8d46c3f8bfbc5-c5bf-1523-e054-00144ff8d46c2015-01-10WarningsExact identifier
spl id: 3f8bfbc5-c5c0-1523-e054-00144ff8d46c
spl set id: 3f8bfbc5-c5bf-1523-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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