FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Soapbox Soaps, LLC | BMC 1092, Inc. dba Solo Laboratories, Inc.
Effective date
2020-04-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:56

Label at a glance#

ProductHand Sanitizer 62% Alcohol based formula
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

for hand washing to decrease bacteria on the skin recommended for repeated use

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

store at room temperature may discolor certain fabrics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for hand washing to decrease bacteria on the skin
  • recommended for repeated use

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of reach of children. If swallowed get medical help or contact poison control center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other Information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • may discolor certain fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Peg-60 Almond Glycerides, Aloe Barbadensis Leaf Juice, Triisopropanolamine, Fragrance

Questions or Comments ?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

DIST. BY SOAPBOX SOAPS LLC | WASHINGTON, D.C. 20007

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOAPBOX®

HAND
SANITIZER

• 62% ALCOHOL •
BASED FORMULA

  • HELPS REDUCE PATHOGENIC
    GERMS ON HANDS
  • WITH MOISTURIZERS
    & VITAMIN E

12 FL OZ (354 mL)

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75115-772-122023-01-30C16284748780-1f386c649-e51c-0266-e053-dadaa90a7c1aHand Sanitizer 62% Alcohol based formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75115-772-12Hand Sanitizer 62% Alcohol based formula354 mL in 1 BOTTLEGEL3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75115-772HAND SANITIZER 62% ALCOHOL BASED FORMULA (ALCOHOL) GEL [SOAPBOX SOAPS, LLC]1Legacy NDC, 1 package rows20200420_7bcce0b8-859b-4668-b17e-3d94e7cb417a.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75115-77275115-772-12

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
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
PEG-60 ALMOND GLYCERIDES4Y0E651N0FIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIISOPROPANOLAMINEW9EN9DLM98IACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT

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
1c53ca8b-ba90-478f-8c67-d198c47e80137bcce0b8-859b-4668-b17e-3d94e7cb417a2020-04-17WarningsExact identifier
spl id: 1c53ca8b-ba90-478f-8c67-d198c47e8013
spl set id: 7bcce0b8-859b-4668-b17e-3d94e7cb417a

Reported adverse events (FAERS/openFDA)#

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