FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Manufacturer
Body One Products , Inc. | BMC 1092, Inc. dba Solo Laboratories, Inc.
Effective date
2020-08-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:11

Label at a glance#

ProductAntibacterial Hand Sanitizer
Active ingredientAlcohol
Label structure9 sections

Indications and uses

for handwashing to decrease bacteria on the skin recommended for repeated use.

Dosage and administration

wet hands thoroughly with product briskly rub hands together until dry supervise children in the use of this product

Storage and handling

store at 20° to 20°C (68 to 77° F) 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 handwashing to decrease bacteria on the skin
  • recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not use in the eyes. In case of contact, rinse eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop and presist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children in the use of this product

Other information

STORAGE AND HANDLING SECTION

  • store at 20° to 20°C (68 to 77° F)
  • may discolor certain fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,PEG 60 Almond Glycerides, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate,Triisopropanolamine, Fragrance

PRINCIPAL DISPLAY PANEL - 1064 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BodyOne
Products

ANTIBACTERIAL
HAND SANITIZER

kills 99.99%
of all germs

(32 FL.OZ. 1064ML)

PRINCIPAL DISPLAY PANEL - 1064 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 1064 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN2
581660ethanol 0.62 ML/ML Topical GelSCD2
581660ethanol 62 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73563-080-012023-01-30C16284748780-1f386c64a-42ba-0266-e053-dadaa90a7c1aAntibacterial Hand Sanitizer
73563-080-022023-01-30C16284748780-1f386c64a-42ba-0266-e053-dadaa90a7c1aAntibacterial Hand Sanitizer
73563-080-042023-01-30C16284748780-1f386c64a-42ba-0266-e053-dadaa90a7c1aAntibacterial Hand Sanitizer
73563-080-062023-01-30C16284748780-1f386c64a-42ba-0266-e053-dadaa90a7c1aAntibacterial Hand Sanitizer
73563-080-072023-01-30C16284748780-1f386c64a-42ba-0266-e053-dadaa90a7c1aAntibacterial Hand Sanitizer
73563-080-082023-01-30C16284748780-1f386c64a-42ba-0266-e053-dadaa90a7c1aAntibacterial Hand Sanitizer
73563-080-122023-01-30C16284748780-1f386c64a-42ba-0266-e053-dadaa90a7c1aAntibacterial Hand Sanitizer
73563-080-182023-01-30C16284748780-1f386c64a-42ba-0266-e053-dadaa90a7c1aAntibacterial Hand Sanitizer
73563-080-322023-01-30C16284748780-1f386c64a-42ba-0266-e053-dadaa90a7c1aAntibacterial Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73563-080-01Antibacterial Hand Sanitizer29.5 mL in 1 TUBEGEL29.52
73563-080-02Antibacterial Hand Sanitizer59 mL in 1 BOTTLEGEL592
73563-080-04Antibacterial Hand Sanitizer3785 mL in 1 BOTTLEGEL37852
73563-080-06Antibacterial Hand Sanitizer66 mL in 1 TUBEGEL662
73563-080-07Antibacterial Hand Sanitizer7 mL in 1 PACKETGEL72
73563-080-08Antibacterial Hand Sanitizer236 mL in 1 BOTTLEGEL2362
73563-080-12Antibacterial Hand Sanitizer355 mL in 1 BOTTLE, PUMPGEL3552
73563-080-18Antibacterial Hand Sanitizer532 mL in 1 BOTTLEGEL5322
73563-080-32Antibacterial Hand Sanitizer1064 mL in 1 BOTTLEGEL10642

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73563-080ANTIBACTERIAL HAND SANITIZER (ALCOHOL) GEL [BODY ONE PRODUCTS , INC.]2Legacy NDC, 9 package rows20200808_c7a71bad-cf25-4742-8f38-cf5a654dfcf2.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
73563-08073563-080-02, 73563-080-18, 73563-080-32, 73563-080-08, 73563-080-04, 73563-080-01, 73563-080-06, 73563-080-07, 73563-080-12

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
cf871b78-7f5a-4339-adf2-bcb95a11b949c7a71bad-cf25-4742-8f38-cf5a654dfcf22020-08-07WarningsExact identifier
spl id: cf871b78-7f5a-4339-adf2-bcb95a11b949
spl set id: c7a71bad-cf25-4742-8f38-cf5a654dfcf2

Reported adverse events (FAERS/openFDA)#

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