Professional Choice Gold Hand Cleaner 404

Professional Choice Gold Hand Cleaner 404

Drug Labeling and Warnings

Drug Details

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PROFESSIONAL CHOICE GOLD HAND CLEANER- parachlorometaxylenol liquid 
Inopak, Ltd.

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 404

Active Ingredient

Parachlorometaxylenol

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 Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water.

Professional Choice Gallon Label

PCSGS1

1 Gallon

             √

Professional™

           Choice

Gold Antibacterial Hand Cleaner

Limpiador Antimicrobiano Para Las Manos

40232 65082   Manufactured for Professional Choice

                           PO Box 1057 Oaks, PA

                           MADE        USA

                           IN THE

4032 65082

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.

Professional Choice Gallon Label

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 Gallon Case Label

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 Box Front

Professional Choice Single Box Back

          5031

Upside down section

             √

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.Section 1

2.Section 2

3.Section 3

4.Section 4

Professional Choice Box Back

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

Professional Choice Single Case

PROFESSIONAL CHOICE GOLD HAND CLEANER 
parachlorometaxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58575-404
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58575-404-013785 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/2018
2NDC: 58575-404-0215140 mL in 1 CASE; Type 0: Not a Combination Product01/01/2018
3NDC: 58575-404-03800 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/2018
4NDC: 58575-404-049600 mL in 1 CASE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2018
Labeler - Inopak, Ltd. (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd.194718243manufacture(58575-404)

Revised: 10/2019
 
Inopak, Ltd.


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