North Woods Derma Foam Hand Sanitizer (Benzalkonium Chloride) Soap [Superior Chemical Corporation] -

NORTH WOODS DERMA FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOAP [SUPERIOR CHEMICAL CORPORATION]
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NDC	53125-700-54, 53125-700-57
Set ID	861e2386-96cf-8b8e-e053-2991aa0ac57a
Category	HUMAN OTC DRUG LABEL
Packager	Superior Chemical Corporation
Generic Name
Product Class
Product Number
Application Number	PART333A

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ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.13%
INDICATIONS & USAGE
Uses
- Use in a variety of public facilities.
- Use this product when soap and water are not available.
WARNINGS
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.
DOSAGE & ADMINISTRATION
Directions
- Read the entire label before using this product.
- Dispense product onto dry hands. Rub hands together until hands are dry.
- Use as needed between hand washes to reduce bacteria on the skin.
INACTIVE INGREDIENT

Inactive Ingredients

Deionized Water, Sodium PCA, PEG/PPG-8/3 Laurate, Dimethicone, DMDM Hydantoin, PEG-3 Cocamide, Fragrance, Iodoproynyl Btylcarbamate, D&C Green #5.
QUESTIONS

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

MDS information:(800) 891-4965
PURPOSE

Purpose

Antiseptic
KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN
Superior Derma Foam Hand Sanitizer

75229-00_Superior Derma Foam Hand Sanitizer.

INGREDIENTS AND APPEARANCE

NORTH WOODS DERMA FOAM HAND SANITIZER
benzalkonium chloride soap

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PEG-3 COCAMINE (UNII: KTM00873VC)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53125-700-57	550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2015
2	NDC:53125-700-54	1000 mL in 1 BAG; Type 0: Not a Combination Product	10/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/01/2015

Labeler - Superior Chemical Corporation (023335086)

Registrant - Betco corporation, Ltd. (024492831)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corporation, Ltd.		024492831	manufacture(53125-700) , pack(53125-700) , label(53125-700)

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