PREMIUM ANTIBACTERIAL SKIN CLEANSER- chloroxylenol soap

Premium Antibacterial Skin Cleanser by

Drug Labeling and Warnings

Premium Antibacterial Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Betco Corporation, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

3780 mL - NDC:

65601-706-04

Active Ingredient

Chloroxylenol 0.5%

Purpose

Antibacterial

Uses

• ​​Antibacterial hand cleanser.
• Use in daycare centers, hospitals, nursing homes, physician offices, dental offices and clinics.

Warnings

• For external use only.
• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Discontinue use if irritation or redness develops.
• If irritation persists for more than 72 hours, consult a physician.

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

• ​Read the entire label before using this product.
• Dispense 2 pumps of product onto palm of hand and scrub thoroughly overall surfaces of both hands.
• Rinse with clean water.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Phenoxyethanol, Ethanol, Glycerin, Sodium Chloride, Surfactant, Tetrasodium EDTA, Allantoin, Ethoxylated Alcohols, Methanol, Magnesium Nitrate, Trisodium Nitrilotriacetate, FD&C Yellow #5, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

SPL UNCLASSIFIED SECTION

©2017 Betco Corporation
400 Van Camp Road | Bowling Green, Ohio 43402
Made In U.S.A. | All Rights Reserved.

888-GO BETCO (888-462-3826) | Betco.com

1100 mL - NDC:

65601-706-10

Active Ingredient

Chloroxylenol 0.5%

Purpose

Antibacterial

Uses

• Antibacterial skin cleanser.
• Use in daycare centers, hospitals, nursing homes, physician offices, dental offices, and clinics.

Warnings

• ​For external use only.
• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Discontinue use if irritation or redness develops.
• If irritation persists for more than 72 hours, consult a physician.

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

• Read the entire label before using this product.
• Dispense 2 pumps of product onto palm of hadn and scrub thoroughly over all surfaces of both hands
• Rinse with clean water.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Phenoxyethanol, Ethanol, Glycerin, Sodium Chloride, Surfactant, Tetrasodium EDTA, Allantoin, Ethoxylated Alcohols, Methanol, Magnesium Nitrate, Trisodium Nitrilotriacetate, FD&C Yellow #5, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

SPL UNCLASSIFIED SECTION

100 mL MORE!*

LOADING INSTRUCTIONS: 1. Open the dispenser. 2. Tear off the perforated tab on the front of this box. 3. Pull out the nozzle. 4. Orient nozzle to properly align with slot near bottom of dispenser. 5. Close dispenser cover and pump to prime. 6. When empty remove box and nozzle from unit and replace.

*100 mL MORE THAN INDUSTRY STANDARD

©2017 Betco Corporation
400 Van Camp Road Bowling Green, Ohio 43402
Made In U.S.A. All Rights Reserved.

888-GO BETCO (888-462-3826) Betco.com 736 1.1 L (37.1 fl. oz.) 1.16 qt.

900 mL - NDC:

65601-706-19

Active Ingredient

Chloroxylenol 0.5%

Purpose

Antibacterial

Uses

• Antibacterial skin cleanser
• Use in daycare centers, hospitals, nursing homes, physician offices, dental offices and clinics.

Warnings

• For external use only.
• Avoid contact with eyes.
• If contact occurs, rinse thoroughly with water.
• Discontinue use if irritation or redness develops.
• If irritation persists for more than 72 hours, consult a physician.

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

• Read the entire label before using this product.
• Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
• Rinse with clean water.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Phenoxyethanol, Ethanol, Glycerin, Sodium Chloride, Surfactant, Tetrasodium EDTA, Allantoin, Ethoxylated Alcohols, Methanol, Magnesium Nitrate, Trisodium Nitrilotriacetate, FD&C Yellow #5, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

SPL UNCLASSIFIED SECTION

100 mL MORE!*

LOADING INSTRUCTIONS: 1. Open the dispenser. 2. Tear off the perforated tab on the front of this box. 3. Pull out the nozzle. 4. Orient nozzle to properly align with slot near bottom of dispenser. 5. Close dispenser cover and pump to prime. 6. When empty remove box and nozzle from unit and replace.

*100 mL MORE THAN INDUSTRY STANDARD.

©2017 Betco Corporation
400 Van Camp Road | Bowling Green, Ohio 43402
Made In U.S.A. | All Rights Reserved.

888-GO BETCO (888-462-3826) | Betco.com

3780 mL - NDC:

65601-706-04

BETCO

Premium Antibacterial Lotion Skin Cleanser

Premiun Antibacterial Skin Cleanser with Chloroxylenol (PCMX), Aloe and Allantoin

SKIN CLEANSER 736

1 gal. (3.78 L)

1100 mL - NDC:

65601-706-10

BETCO

Premium Antibacterial Lotion Skin Cleanser

Premiun Antibacterial Skin Cleanser with Chloroxylenol (PCMX), Aloe and Allantoin

SKIN CLEANSER 736

1.1 L (37.1 fl. oz.) 1.16 qt.

900 mL - NDC:

65601-706-19

BETCO

Premium Antibacterial Lotion Skin Cleanser

Premiun Antibacterial Skin Cleanser with Chloroxylenol (PCMX), Aloe and Allantoin

SKIN CLEANSER 736

900 mL (30.4 fl. oz) 1.9 pt.

INGREDIENTS AND APPEARANCE

PREMIUM ANTIBACTERIAL SKIN CLEANSER 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65601-706
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BERACTANT (UNII: S866O45PIG)
EDETATE SODIUM (UNII: MP1J8420LU)
ALLANTOIN (UNII: 344S277G0Z)
C20-40 PARETH-95 (UNII: CLW2OA0Q1K)
METHYL ALCOHOL (UNII: Y4S76JWI15)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65601-706-19	900 mL in 1 BAG; Type 0: Not a Combination Product	06/01/2016
2	NDC: 65601-706-10	1100 mL in 1 BAG; Type 0: Not a Combination Product	06/01/2016
3	NDC: 65601-706-04	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2016

Labeler - Betco Corporation, Ltd. (024492831)

Registrant - Betco Corporation, Ltd. (024492831)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corporation, Ltd.		024492831	label(65601-706) , manufacture(65601-706) , pack(65601-706)