FDA.reportPublic FDA data

Handsanitizer

Manufacturer
Bathletix
Effective date
2020-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:29

Label at a glance#

ProductHandsanitizer Antibacterial Gel
Active ingredientAlcohol
Label structure8 sections

Indications and uses

Hand sanitzer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitzer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable. Keep away from heat or flame

Do Not Use

OTC - DO NOT USE SECTION

  • In children less than 2 months of age
  • On open skin wounds

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

OTHER SAFETY INFORMATION

  • Store at temperature below 110°F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

*Water, Glycerin, Hydroxypropyl Guar, Citric Acid, Calendula Officinalis Flower Extract, Chomomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice.

Principal Display Panel – 30 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bathletix®
HAND
SANITIZER

ANTI-BACTERIAL GEL
WITH ALOE VERA

KILLS 99.9%
OF GERMS

1 fl.oz./30ml

Figure
Figure

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90108-050-002022-01-28C16284748780-1d6a99b39-45cd-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90108-050-00Handsanitizer Antibacterial Gel1 in 1 BOTTLELIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90108-050HANDSANITIZER ANTIBACTERIAL GEL (ALCOHOL) LIQUID [BATHLETIX]1Legacy NDC, 1 package rows20200901_ca45395a-74e2-4fa3-b3ab-a63d6a14f254.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
90108-05090108-050-00

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
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
GUARAPROLOSE (1300 MPA.S AT 1%)1530WMS90SIACT
Aloe Vera LeafZY81Z83H0XIACT
Citric Acid Monohydrate2968PHW8QPIACT
Calendula Officinalis FlowerP0M7O4Y7YDIACT
Matricaria Chamomilla WholeG0R4UBI2ZZIACT

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
09b75854-d6af-41c3-b7a8-b1f2c3e2ce55ca45395a-74e2-4fa3-b3ab-a63d6a14f2542020-08-24WarningsExact identifier
spl id: 09b75854-d6af-41c3-b7a8-b1f2c3e2ce55
spl set id: ca45395a-74e2-4fa3-b3ab-a63d6a14f254

Reported adverse events (FAERS/openFDA)#

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