FDA.reportPublic FDA data

Hand Sanitizing Gel Orange Oil

Manufacturer
PureTek Corporation
Effective date
2020-05-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:28:08

Label at a glance#

ProductHand Sanitizing
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

■ Hand sanitizer to help reduce bacteria on the skin

Dosage and administration

■ Dispense and rub onto hands until dry. Do not rinse off. ■ Children under 6 years of age should use this product under supervision. ■ repeat as necessary

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% (v/v)

Purpose

OTC - PURPOSE SECTION

Anti-Bacterial

Uses

INDICATIONS & USAGE SECTION

■ Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

■ Flammable. Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

■ do not use in or near eyes. In case of contact, rinse eyes throughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ irritation or redness develop and last for more than 72 hours

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

■ Dispense and rub onto hands until dry. Do not rinse off.

■ Children under 6 years of age should use this product under supervision.

■ repeat as necessary

Other information

SPL UNCLASSIFIED SECTION

■ Do not store above 110°F (43°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (aloe vera) Leaf Juice, Aminomethyl Propanol, Butyrospermum Parkii (Shea)
Butter, Carbomer, Glycerin, Isopropyl Myristate, Citrus aurantium dulcis (Orange) Peel Oil, Panthenol, Water (Aqua).

GenRx Hand Sanitizing Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-37059088-370-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
CITRUS AURANTIUM FRUIT RIND055456JHI7IACT
ALCOHOL3K9958V90MACTIB

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
a9419276-8767-a801-e053-2995a90a3a9ea5b3d03c-fe78-5955-e053-2995a90a97842020-06-29WarningsExact identifier
spl set id: a5b3d03c-fe78-5955-e053-2995a90a9784

Reported adverse events (FAERS/openFDA)#

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