FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
McKenzie Creative Brands, LLC
Effective date
2022-03-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:05:03

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

Store between 59-86°F (15-30°C) Avoid freezing and excessive heat above 104°F (40°C) Replace cap tightly after use. Dispense directly from original container. Not for refill purposes.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 64% v/v

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

in children less than 2 months of age

on open skin wounds

OTC - WHEN USING SECTION

When using this product 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 a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

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.

STORAGE AND HANDLING SECTION

Store between 59-86°F (15-30°C)

Avoid freezing and excessive heat above 104°F (40°C)

Replace cap tightly after use.

Dispense directly from original container. Not for refill purposes.

INACTIVE INGREDIENT SECTION

water, aloe barbadensis leaf juice, isopropyl myristate, glycerin, triethanolamine, carbomer, fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 oz Container Front8 oz Container Front8 Oz Container Rear8 Oz Container RearHalf Gallon Container LabelHalf Gallon Container LabelGallon Container LabelGallon Container Label

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78200-00478200-004-08, 78200-004-64, 78200-004-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
LINALYL ACETATE5K47SSQ51GIACT
CITRONELLA OILQYO8Q067D0IACT
OCTOXYNOL-848RF3T316OIACT
NONOXYNOL-948Q180SH9TIACT
COUMARINA4VZ22K1WTIACT
NEROL38G5P53250IACT
ORANGE OILAKN3KSD11BIACT
GERANIOLL837108USYIACT
4-TERT-BUTYLCYCLOHEXYL ACETATE21EUM2B8UCIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
LINALOOL, (+/-)-D81QY6I88EIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
LIME OILUZH29XGA8GIACT
CITRALT7EU0O9VPPIACT
10-UNDECENALDU1OTA08RYIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
TROLAMINE9O3K93S3TKIACT

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
daf8ef5b-79ac-c56b-e053-2995a90a99c3bc2af2d5-3004-6ddf-e053-2995a90a48ca2022-03-24WarningsExact identifier
spl id: daf8ef5b-79ac-c56b-e053-2995a90a99c3
spl set id: bc2af2d5-3004-6ddf-e053-2995a90a48ca

Reported adverse events (FAERS/openFDA)#

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