FDA.reportPublic FDA data

Ultimate Solutions Antiseptic Gold

Manufacturer
Ultimate Solutions
Effective date
2023-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:39:49

Label at a glance#

ProductUltimate Solutions Antiseptic Gold
Active ingredientCHLOROXYLENOL
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Parachlorometaxylenol 0.3% w/w

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • Handwash to decrease bacteria on the skin that potentially can cause disease.
  • Recommended for repeated use.

WARNINGS SECTION

Warnings

  • For external use only.

OTC - WHEN USING SECTION

  • Keep out of eyes, ears or mouth. In case of eye contact, flush with water.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if irritation and redness develop or if condition persists more than 72 hours.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Wet hands with water and dipense sufficient amount of product into cupped palm of hand.
  • Wash thoroughly for 15 seconds.
  • Rinse under running water and dry thoroughly.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Citric Acid, Cocamide DEA, FD&C Red 4, DMDM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water

SPL UNCLASSIFIED SECTION

Ultimate Solutions. Inc.

Englewood, NJ 07631

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic GoldAntiseptic Gold

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81571-00281571-002-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO DIETHANOLAMIDE92005F972DIACT
FD&C RED NO. 4X3W0AM1JLXIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
DMDM HYDANTOINBYR0546TOWIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
CHLOROXYLENOL0F32U78V2QACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT

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
f279bc4e-a488-8d17-e053-2995a90a3209bb9fe716-4e8d-2e31-e053-2a95a90abf432023-01-02WarningsExact identifier
spl id: f279bc4e-a488-8d17-e053-2995a90a3209
spl set id: bb9fe716-4e8d-2e31-e053-2a95a90abf43

Reported adverse events (FAERS/openFDA)#

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