FDA.reportPublic FDA data

HEALTH SMART ANTIBACTERIAL HAND SWEET PEA ORCHID

Manufacturer
International Wholesale Inc
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:17:49

Label at a glance#

ProductHEALTH SMART ANTIBACTERIAL HAND SWEET PEA ORCHID
Active ingredientCHLOROXYLENOL
Label structure7 sections

Indications and uses

for hand washing to help eliminate bacteria on the skin.

Dosage and administration

pump into hands lather vigorously for at least 15 seconds rinse and dry thoroughly.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.3%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

for hand washing to help eliminate bacteria on the skin.

Warnings

WARNINGS SECTION

for external use only.

When using this product:

OTC - WHEN USING SECTION

avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

irritation and redness develops.

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

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly.

Other Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.   

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth ulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Chloride, Fragrance, Glycerin, Citric Acid, PEG-150 Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Red No.40, FD&C Yellow No.5

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52862-60352862-603-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CHLOROXYLENOL0F32U78V2QACTIB

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
19b16dbe-c5eb-c951-e063-6294a90ac046ca77ef96-d975-41d9-bc8d-2573f7c2c40b2024-05-30WarningsExact identifier
spl set id: ca77ef96-d975-41d9-bc8d-2573f7c2c40b

Reported adverse events (FAERS/openFDA)#

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