FDA.reportPublic FDA data

Kelley's Hand Sanitizer Gel 65%

Manufacturer
K2 Distribution Company LP
Effective date
2020-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:06:28

Label at a glance#

ProductAlcohol
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions Apply product generously in palm using enough to cover hands. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Ethyl Alcohol 65% v/v

Purpose

OTC - PURPOSE SECTION

Purpose Antimicrobial

Use

INDICATIONS & USAGE SECTION

Use Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

Warnings

  • Flammable. Keep away from fire and flame
  • For external use only

When using thiss product

OTC - WHEN USING SECTION

When using thiss product avoid use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

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 Poison Control.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions Apply product generously in palm using enough to cover hands. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Other information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun. Store below 110°F (43°C).
  • May discolor some fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Hydroxyethylcellulose, Glycerin, Menthol, Cocoyl Argininamide, Safflower Acids, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Coconut Acids, Eucalyptus Globulus Leaf Oil, Caprylyl Glycol, Fragrance, 1,2-Hexanediol, Disodium EDTA-Copper.

Questions

OTC - QUESTIONS SECTION

Customer Service 888-458-1038

SPL UNCLASSIFIED SECTION

Kelley's Hand Sanitizer Gel

KILLS HARMFUL BACTERIA AND GERMS

Distributed by: K2 Distribution

128 fl oz (3785.4 ml)

triclosan, Sulfate & Paraben-Free

NOT FOR RESALE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78039-05178039-051-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SAFFLOWER ACIDY788KS82OVIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB
DISODIUM EDTA-COPPER6V475AX06UIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCONUT ACID40U37V505DIACT
GLYCERINPDC6A3C0OXIACT
EUCALYPTUS OIL2R04ONI662IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT

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
b47e2fe3-921c-161e-e053-2995a90ae4bea71d0011-1751-60d4-e053-2a95a90ad0832020-11-19WarningsExact identifier
spl id: b47e2fe3-921c-161e-e053-2995a90ae4be
spl set id: a71d0011-1751-60d4-e053-2a95a90ad083

Reported adverse events (FAERS/openFDA)#

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