KNUCKLE UNDER MEDICATED- chloroxylenol soap
Betco Corporation, 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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Knuckle Under Medicated Lotion Skin Cleanser

Medicated Lotion Skin Cleanser

Active Ingredient

Chloroxylenol 0.5%

Knuckle Under Medicated

Uses

For use in a variety of industrial setting including manufacturing, machine shops, maintenance areas and automotive shops.

Knuckle Under Medicated

Warnings

For external use only.
Avoid contact with eyes.
If contact occurs, rinse thoroughly with water.
Discontinue use is irritation or redness develops.
If irritation persists for more than 72 hours, consult a physician.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a poison control center right away.

Knuckle Under Medicated

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.

Knuckle Under Medicated

Inactive Ingredients

Water, sodium tallate, Sodium Laureth Sulfate, Triisopropanolamine, Alcohol, Tetrasodium EDTA, Sodium Chloride, Coco MIPA, Fragrance, Cocamidopropropyl Betaine, Glycerin, Methyl Chlorosiothiazolinone, D&C Green #5, FD&C Yellow #5.

Knuckle Under Medicated

Purpose

Antibacterial

Knuckle Under Medicated

KEEP OUT OF REACH OF CHILDREN

Medicated Lotion Skin Cleanser

label-1

label-2

label-3

KNUCKLE UNDER MEDICATED
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65601-765
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
EDETATE SODIUM (UNII: MP1J8420LU)
TALL OIL ACID (UNII: H9HR63474M)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLENEDIAMINETETRAACETIC ACID (UNII: 3F6OA94EER)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65601-765-19	900 mL in 1 BAG; Type 0: Not a Combination Product	11/12/2012	01/01/2016
2	NDC:65601-765-10	1100 mL in 1 BAG; Type 0: Not a Combination Product	11/12/2012	01/01/2016
3	NDC:65601-765-04	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2016	07/15/2020
4	NDC:65601-765-06	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/12/2012	07/15/2020
5	NDC:65601-765-55	208000 mL in 1 DRUM; Type 0: Not a Combination Product	11/12/2012	07/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/12/2012	07/15/2020

Labeler - Betco Corporation, Ltd. (024492831)

Registrant - Betco corporation, Ltd. (024492831)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corporation, Ltd.		024492831	manufacture(65601-765) , label(65601-765) , pack(65601-765)

Revised: 7/2020

Document Id: aa918b1f-8e6c-10d3-e053-2995a90a8e77

Set id: 78e7ae2a-7c20-4fb2-bb92-2b1505323586

Version: 8

Effective Time: 20200716

Betco Corporation, Ltd.