ANTIBACTERIAL- chloroxylenol liquid

Antibacterial by

Drug Labeling and Warnings

Antibacterial 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%

Purpose

Antiseptic

Use

• 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 or 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.

Keep out of Reach of 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 minutes.
• Rinse under running water and dry thoroughly.

Inactive ingredients

Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water.

Pouch Label

ENCORE™

INDUSTRIAL PRODUCTS

H110 EPI FOAM

Antibacterial Foaming Hand Wash With 0.3% PCMX

1000 ml

(33.9 fl.oz.)

MADE IN THE USA

Encore Industrial Products

3502 Bacor Rd. Houston, TX 77084

1-877-703-3044

www.encoreindustrial.com

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.
• Stop use and ask a doctor if irritation or 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 minutes.
• Rinse under running water and dry thoroughly.

Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water.

Questions? Call 1-877-703-3044 or visit our website www.encoreindustrial.com

Case Label

ENCORE™

INDUSTRIAL PRODUCTS

H110 EPI FOAM

Antibacterial Foaming Hand Wash With 0.3% PCMX

Encore Industrial Products

3502 Bacor Rd. Houston, TX 77084

1-877-703-3044 www.encoreindustrial.com

MADE IN THE USA

4/1000

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-507
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
sodium laureth sulfate (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-507-01	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	12/01/2017
2	NDC: 58575-507-02	4000 mL in 1 CASE; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2017

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-507)