Professional Choice Gold Hand Cleaner

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]

PROFESSIONAL CHOICE GOLD HAND CLEANER- chloroxylenol liquid 
Sheppard Enterprises, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Professional Choice Gold Hand Cleaner

Drug Facts

Active ingredient

Parachlorometaxylenol 0.3% w/w

Purpose

Antiseptic

Uses

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

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.

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 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.

1 Gallon

Professional Choice

Gold Antibacterial Hand Cleaner

Manufactured for Professional Choice

P.O. Box 1057 - Oaks, PA

MADE IN THE USA

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)

Revised: 1/2023

Document Id: f279ad80-1742-6497-e053-2995a90a796c

34390-5

Set id: d0753c6f-d4b7-bb21-e053-2995a90ad6d1

Version: 2

Effective Time: 20230102