Choice Liquid Antibacterial Soap  407

Choice Liquid Antibacterial Soap  407

Drug Labeling and Warnings

Drug Details

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CHOICE LIQUID ANTIBACTERIAL- 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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Choice Liquid Antibacterial Soap  407

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. In case of eye contact, flush eyes with water.

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.

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.

Choice Liquid Antibacterial Soap Single Label

Rev. 1.01

Broad

Spectrum

Germ Control

Contains

.3%

P.C.M.X

Choice

LIQUID

ANTIBACTERIAL

SOAP

With Moisturizers

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.

Questions? Call 1-800-767-7725 or visit our website www.inopack.com

Choice Single label

Choice Case label

Broad

Spectrum

Germ Control

Contains

.3%

P.C.M.X

Choice

LIQUID

ANTIBACTERIAL

SOAP

With Moisturizers

O   12/800 ml UV

      5031-404UV-CH

      0 40232 65079 6

O   4/1 Gallon

      5031-420-02CH

      0 40232 65069 7

MADE

IN THE

USA

5031-CH-CS

Rev. 1.0

Choice Case label

Choice Box front label

401-1-80

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.

Choice

LIQUID ANTIBACTERIAL SOAP

With Moisturizers

Contains

.3% P.C.M.X.

PN-5031-404UV-CH

800 ml

Choice box front label

Choice box back label

Choice

LIQUID ANTIBACTERIAL SOAP

  LIQUID ANTIBACTERIAL SOAP

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

Broad

Spectrum

Germ

Control

MADE

IN THE

USA

Choice

       Dispenser Loading Instructions

1.

2.

3.

4.

Section 1Section 2

Section 3Section 4

Choice box label back

CHOICE LIQUID ANTIBACTERIAL 
parachlorometaxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58575-407
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
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58575-407-013785 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/2018
2NDC: 58575-407-02800 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/2018
3NDC: 58575-407-039600 mL in 1 CASE; Type 0: Not a Combination Product01/01/2018
4NDC: 58575-407-0415140 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, Lt.194718243manufacture(58575-407)

Revised: 10/2019
 
Inopak, Ltd.


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