PROBALANCE Hand Sanitizer Advanced Gel

Manufacturer
LTD ENTERPRISES DISTRIBUTION, INC.
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:02

Label at a glance#

ProductPROBALANCE Hand Sanitizer Advanced
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Directions place enough product in your palm to thoroughly cover your hands and rub hands together until dry. children under 6 years should be supervised when using this product.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

PROBALANCE Hand Sanitizer Advanced Gel

Drug Facts

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from source of heat, fire or flame.

For external use only. Not for Consumption.

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and lasts.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • place enough product in your palm to thoroughly cover your hands and rub hands together until dry.
  • children under 6 years should be supervised when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, hydroxypropyl guar, citric acid

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Other information

SPL UNCLASSIFIED SECTION

Other information

  • store at a temperature below 110 F (43 C).
  • may discolor certain fabrics or surfaces.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

78072-501-10 - 1 gallon

One Gallon LabelOne Gallon Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78072-501-082022-01-28C16284748780-1d6a99b39-a6d1-a426-e053-dadaa90af4c2PROBALANCE Hand Sanitizer Advanced Gel
78072-501-102022-01-28C16284748780-1d6a99b39-a6d1-a426-e053-dadaa90af4c2PROBALANCE Hand Sanitizer Advanced Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78072-501-08PROBALANCE Hand Sanitizer Advanced237 mL in 1 BOTTLEGEL2371
78072-501-10PROBALANCE Hand Sanitizer Advanced3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78072-501PROBALANCE HAND SANITIZER ADVANCED (ALCOHOL) GEL [LTD ENTERPRISES DISTRIBUTION, INC.]1Legacy NDC, 2 package rows20200521_a61a88bb-7326-3bf7-e053-2995a90a5ef3.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78072-50178072-501-10, 78072-501-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
a61a88bb-7327-3bf7-e053-2995a90a5ef3a61a88bb-7326-3bf7-e053-2995a90a5ef32020-05-20WarningsExact identifier
spl id: a61a88bb-7327-3bf7-e053-2995a90a5ef3
spl set id: a61a88bb-7326-3bf7-e053-2995a90a5ef3

Reported adverse events (FAERS/openFDA)#

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