PROFESSIONAL CHOICE GOLD HAND CLEANER- chloroxylenol liquid

Professional Choice Gold Hand Cleaner by

Drug Labeling and Warnings

Professional Choice Gold Hand Cleaner by is a Otc medication manufactured, distributed, or labeled by Sheppard Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Parachlorometaxylenol 0.3% w/w

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

• For external use only.

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

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

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

1 Gallon

Professional Choice

Gold Antibacterial Hand Cleaner

Manufactured for Professional Choice

P.O. Box 1057 - Oaks, PA

MADE IN THE USA

INGREDIENTS AND APPEARANCE

PROFESSIONAL CHOICE GOLD HAND CLEANER 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82175-404
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALCOHOL (UNII: 3K9958V90M)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82175-404-01	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	11/10/2021	07/19/2024
2	NDC: 82175-404-03	800 mL in 1 CONTAINER; Type 0: Not a Combination Product	11/10/2021	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/10/2021	07/29/2024

Labeler - Sheppard Enterprises, Inc. (144668444)