PROFESSIONAL CHOICE GOLD HAND CLEANER- parachlorometaxylenol 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 Inopak, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Keep out of reach of children. If swallowed, get

   medical help or contact a Poison Control Center

   right away.

When using

Keep out of eyes, ears, or mouth. 

Stop using

 If swallowed, get

   medical help or contact a Poison Control Center

   right away.

Keep away from Children

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 Ingredient

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

Professional Choice Gallon Label

• PCSGS1 1 Gallon Professional™ Choice Gold Antibacterial Hand Cleaner Limpiador Antimicrobiano Para Las Manos:

  Drug Facts

  Active Ingredient Purpose

  Parachlorometaxylenol 0.3% w/w……. 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.

  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 4, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium, Water

• 040232 65082 6:

  Manufactured for Professional Choice

  PO Box 1057 Oaks, PA

  MADE IN THE USA

Professional Choice Gallon Case Label 

40232 65084

             √

Professional™

           Choice

Gold Antibacterial Hand Cleaner

Limpiador Antimicrobiano Para Las Manos

PCSGS1                                Manufactured for Professional Choice

4/Gallon                               PO Box 1057 Oaks, PA

MADE        USA

IN THE

Professional Choice Single Container Box Front

404-1-PCSGS800 Rev.01 Drug Facts Active Ingredient                                   Purpose Parachlorometaxylenol 0.3% w/w…. 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. 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, DMOM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water. Manufactured for Professional Choice                 PO Box 1057 Oaks, PA	√ Professional Choice™
	Gold Antibacterial Hand Cleaner		Limpiador Antimicrobiano Para Las Manos
	Broad Spectrum Germ Control		Contains .3% P.C.M.X.
	MADE IN THE USA		PCSGS800 800 ml

Professional Choice Single Box Back

• √ Professional Choice ™ Gold Antibacterial Hand Cleaner Limpiador Antimicrobiano Para Las Manos Antibacterial soap can help reduce bacteria on the hands that cause disease PH balanced Produced in an FDA registered facility cGMP facility Mild formula for multiple handwashing without stripping the skin of its natural oils 40232 65081:

  √

  Professional Choice ™

  Dispenser Loading Instructions

• 1.:

  2.

• 3.:

  4.

Professional Choice Single Unit Case 

4032 65083

             √

Professional™

           Choice

Gold Antibacterial Hand Cleaner

Limpiador Antimicrobiano Para Las Manos

PCSGS1800                         Manufactured for Professional Choice

12/800                                  PO Box 1057 Oaks, PA

MADE        USA

IN THE

INGREDIENTS AND APPEARANCE

PROFESSIONAL CHOICE GOLD HAND CLEANER 
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-404
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 mg  in 1 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)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-404-01	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-404-02	15140 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018
3	NDC: 58575-404-03	800 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2018
4	NDC: 58575-404-04	9600 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2018

Labeler - Inopak, Ltd. (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd.		194718243	manufacture(58575-404)