NORTH WOODS SUPREME ANTISEPTIC HAND CLEANSER- chloroxylenol soap
Superior Chemical Corporation

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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North Woods Supreme Antiseptic Hand Cleanser

Active Ingredient

Chloroxylenol 0.375%

North Woods Supreme Antiseptic Hand Cleanser

Uses

Antibacterial hand cleaner.
Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

North Woods Supreme Antiseptic Hand Cleanser

Warnings

For external use only.
Avoid contact with eyes.
Children under the age of 6 should be supervised by an adult when using this product.
Discontinue use is irritation or redness develops.
If irritation persists for more than 72 hours, consult a physician.
KEEP OUT OF REACH OF CHILDREN.

North Woods Supreme Antiseptic Hand Cleanser

Directions

Read the entire label before using this product.
Dispense 1-2 pumps of product onto wet palm.
Lather and rinse hands with clean water

North Woods Supreme Antiseptic Hand Cleanser

Inactive Ingredients

Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

North Woods Supreme Antiseptic Hand Cleanser

Questions or Comments?Phone: (800) 777-9343

MDS information:(800) 891-4965

North Woods Supreme Antiseptic Hand Cleanser

Purpose

Antibacterial

North Woods Supreme Antiseptic Hand Cleanser

KEEP OUT OF REACH OF CHILDREN

North Woods by Superior Supreme Antiseptic Hand Cleanser

SUperior 141

North Woods by Superior Supreme Antiseptic Hand Cleanser

Lotionized Antibacterial and pH Balanced

Excellence Since 1964

Superior Chemical Corporation

Sheboygan, WI 53081

Superior 141.jpg

NORTH WOODS SUPREME ANTISEPTIC HAND CLEANSER
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53125-141
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCOL STEARATE (UNII: 0324G66D0E)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
GLYCERIN (UNII: PDC6A3C0OX)
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:53125-141-19	900 mL in 1 BAG; Type 0: Not a Combination Product	11/12/2012	04/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/12/2012	04/01/2019

Labeler - Superior Chemical Corporation (023335086)

Registrant - Betco corporation, Ltd. (005050158)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corpo, Ltd.		005050158	manufacture(53125-141)

Revised: 4/2019

Document Id: 861ab013-a8b9-816a-e053-2a91aa0abc1b

Set id: 44c2e515-0772-463c-a067-68bcc5f1f0dd

Version: 3

Effective Time: 20190409

Superior Chemical Corporation