FDA.reportPublic FDA data

Spatherapy Antibacterial Hand Gel, Berry

Manufacturer
Shalom International Corp
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:19:35

Label at a glance#

ProductSpatherapy Antibacterial Berry
Active ingredientALCOHOL
Label structure6 sections

Dosage and administration

Apply to hands until thoroughly wet. Rub vigorously until dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol Denat. 62%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin and clean hands. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from flames.

When using this product

OTC - WHEN USING SECTION

do not get into eye. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develop or persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to hands until thoroughly wet. Rub vigorously until dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Fragrance (Parfum), Carbomer, Aminomethyl Propanol, FD&C Blue No.1, FD&C Yellow No.5.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
73025-16073025-160-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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
1f0766bd-d452-fff8-e063-6394a90abd44b9bb862a-490a-70ec-e053-2a95a90a47472024-08-06WarningsExact identifier
spl set id: b9bb862a-490a-70ec-e053-2a95a90a4747

Reported adverse events (FAERS/openFDA)#

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