NORTH WOODS DERMA FOAM HAND SANITIZER- benzalkonium chloride soap

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Superior Chemical Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - Use in a variety of public facilities. - Use this product when soap and water are not available. Purpose Antiseptic
Authorization status:
OTC monograph not final
Authorization number:
53125-700-54, 53125-700-57

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.

NORTH WOODS DERMA FOAM HAND SANITIZER

benzalkonium chloride soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53125-70 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.3 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM PYRRO LIDO NE CARBO XYLATE (UNII: 46 9 OTG57A2)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

PEG-3 CO CAMINE (UNII: KTM0 0 8 73VC)

Superior Chemical Corporation

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

D&C GREEN NO . 5 (UNII: 8 J6 RDU8 L9 X)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:53125-70 0 -

550 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

10 /0 1/20 15

2

NDC:53125-70 0 -

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

10 /0 1/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

10 /0 1/20 15

Labeler -

Superior Chemical Corporation (023335086)

Registrant -

Betco corporation, Ltd. (024492831)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Betco Co rpo ratio n, Ltd.

0 2449 28 31

manufacture(53125-70 0 ) , pack(53125-70 0 ) , label(53125-70 0 )

Revised: 4/2019

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