FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SJ Creations, Inc. | McKenna Labs, Inc.
Effective date
2021-09-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:35:46

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Put enought on your palm to cover hand and rub hands together briskly until dry. Children under 6 years of age should be supervised when using the product.

Storage and handling

Store between 20-25C (68-77F) May discolor some fabrics or surfaces Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

Do not use

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 avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put enought on your palm to cover hand and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using the product.

Other information

STORAGE AND HANDLING SECTION

  • Store between 20-25C (68-77F)
  • May discolor some fabrics or surfaces
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Carbomer, Fragrance, Isopropyl Palmitate, Aminomethyl Propanol, Tocopheryl Acetate.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CM9509-CCM9509-C236ml NDC: 43269-983-08

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43269-98343269-983-08

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
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER 934Z135WT9208IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
cc1592c4-2589-592f-e053-2995a90a78bbaa86cdee-13ff-3ceb-e053-2995a90a4f0f2021-09-15WarningsExact identifier
spl id: cc1592c4-2589-592f-e053-2995a90a78bb
spl set id: aa86cdee-13ff-3ceb-e053-2995a90a4f0f

Reported adverse events (FAERS/openFDA)#

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