FDA.reportPublic FDA data

Spatherapy Sanitizing Hand Wipes

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#

ProductSpatherapy Sanitizing Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin. recommended for repeat use

Dosage and administration

Storage . Store at room temperature.  Dispensing . Remove seal band. Lift tab at front of lid. Pull up corner of center sheet and thread through dispenser slit in lid. Close lid to retain moisture. Use . Apply wipe thoroughly to hands as desired. Allow to dry without wiping.  Disposal . Dispose of used wipes in trash receptacle after use. Do not flush.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on the skin. recommended for repeat use

Warnings

WARNINGS SECTION

  • For external use only

Do Not Use

OTC - DO NOT USE SECTION

  • In the eyes.
  • if you are allergic to any of the ingredients.

 When using this product

OTC - WHEN USING SECTION

if eye contact occurs, rinse eyes thoroughly with water.

• Stop use & ask a doctor

OTC - STOP USE SECTION

if irritation and redness develop and persist 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

  • Storage. Store at room temperature. 
  • Dispensing. Remove seal band. Lift tab at front of lid. Pull up corner of center sheet and thread through dispenser slit in lid. Close lid to retain
    moisture.
  • Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping. 
  • Disposal. Dispose of used wipes in trash receptacle
    after use. Do not flush.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene glycol, Aloe extract, Glycerol

Questions?

OTC - QUESTIONS SECTION

  • Call 212-391-6970

Package Labeling:20 wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label7Label7

Package Labeling:50 wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label8Label8

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73025-06973025-069-00, 73025-069-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
ea2fb555-1eac-92b2-e053-2a95a90aacbd07f3457a-ac0e-4552-b467-1b42a89d40af2022-10-04WarningsExact identifier
spl set id: 07f3457a-ac0e-4552-b467-1b42a89d40af

Reported adverse events (FAERS/openFDA)#

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