NORTH WOODS DERMA FOAM HAND SANITIZER- benzalkonium chloride 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 Derma Foam Hand Sanitizer

Active Ingredient

Benzalkonium Chloride 0.13%

Uses

Use in a variety of public facilities.
Use this product when soap and water are not available.

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.

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 Ingredients

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

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

MDS information:(800) 891-4965

Purpose

Antiseptic

KEEP OUT OF REACH OF CHILDREN

Superior Derma Foam Hand Sanitizer

75229-00_Superior Derma Foam Hand Sanitizer. 75229 Superior Derma Foam

NORTH WOODS DERMA FOAM HAND SANITIZER
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53125-700
Route of Administration	TOPICAL

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)