FDA.reportPublic FDA data

Jack Nicklaus hand sanitizer

Manufacturer
Shalom International Corp
Effective date
2020-07-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:21:54

Label at a glance#

ProductJack Nicklaus hand sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Dosage and administration

Apply enough product to thoroughly cover hands. Rub hands together briskly until dry.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol Denat. 62%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin that could cause disease.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

  • Flamable. Keep away from fire or flame.
  • For external use only

• When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. Incase of contact, rinse eyes thoroughly with water.

• Stop use & ask a doctor if

OTC - STOP USE SECTION

irritation or rash appears & lasts.

• 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

  • Apply enough product to thoroughly cover hands.
  • Rub hands together briskly until dry.

Other Information

SPL UNCLASSIFIED SECTION

  • Do not store above 110°F (43°C).
  • May discolor certain fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, DMDM Hydantoin, Fragrance(Parfum), Sodium Hydroxide, Tocopheryl Acetate.

Questions?

OTC - QUESTIONS SECTION

  • Call 212-391-6970

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73025-06373025-063-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
DMDM HYDANTOINBYR0546TOWIACT
SODIUM HYDROXIDE55X04QC32IIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
d929f7d0-d8b8-523f-e053-2995a90a99520ed5e5da-888f-4f4d-b990-828a3e64236a2022-03-01WarningsExact identifier
spl set id: 0ed5e5da-888f-4f4d-b990-828a3e64236a

Reported adverse events (FAERS/openFDA)#

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