CHOICE LIQUID ANTIBACTERIAL- parachlorometaxylenol liquid

Choice Liquid Antibacterial by

Drug Labeling and Warnings

Choice Liquid Antibacterial by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd., Inopak, Lt.. 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. 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, D&C Red 4, DMOM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth 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, D&C Red 4, DMOM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water. Questions? Call 1-800-767-7725 or visit our website www.inopack.com

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 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, D&C Red 4, DMOM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water.	Choice LIQUID ANTIBACTERIAL SOAP
			With Moisturizers
	Contains .3% P.C.M.X.
			PN-5031-404UV-CH 800 ml

Choice box back label

• 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

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INGREDIENTS AND APPEARANCE

CHOICE LIQUID ANTIBACTERIAL 
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-407
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-407-01	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-407-02	800 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2018
3	NDC: 58575-407-03	9600 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018
4	NDC: 58575-407-04	15140 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, Lt.		194718243	manufacture(58575-407)