FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SJ Creations, Inc. | Tonic Bath & Body Products Shenzhen Ltd
Effective date
2021-09-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:36:31

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Place enough product on palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store at 20C-25C (68F to 77F) May discolor some fabrics and surfaces

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.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.
In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

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

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store at 20C-25C (68F to 77F)
  • May discolor some fabrics and surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized Aqua (Water), Glycerin, Propylene Glycol, Carbomer, Fragrance (Parfum), Tocopheryl Acetate, Isopropyl Alcohol, Aminomethyl Propanol, Isopropyl Palmitate.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473ml NDC: 43269-115-16 201346201346

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
43269-11543269-115-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL PALMITATE8CRQ2TH63MIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER 9404Q93RCW27EIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOPROPYL ALCOHOLND2M416302IACT
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
cbe6adb5-c8e9-1f2e-e053-2995a90a0e06b0812ebc-de6a-0a34-e053-2995a90ad99f2021-09-13WarningsExact identifier
spl id: cbe6adb5-c8e9-1f2e-e053-2995a90a0e06
spl set id: b0812ebc-de6a-0a34-e053-2995a90ad99f

Reported adverse events (FAERS/openFDA)#

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