ULTRA MILD ANTIBACTERIAL SKIN CLEANSER- 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:
Betco Corporation, Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - ​ ​Antibacterial hand cleaner. - Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics Purpose Antibacterial
Authorization status:
OTC monograph not final
Authorization number:
65601-710-04, 65601-710-10, 65601-710-19, 65601-710-41

ULTRA MILD ANTIBACTERIAL SKIN CLEANSER- benzalkonium chloride 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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Ultra Mild Antibacterial Skin Cleanser

Active Ingredient

Active Ingredient

Benzalkonium Chloride 0.13%

Uses

Antibacterial hand cleaner.

Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

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.

If swallowed, get medical help or contact a Posion Control Center right away.

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.

Inactive Ingredients

Water, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Propylene Glycol, Sodium Chloride,

Glycerin, PEG-4 Rapeseedamide, Dimethicone PEG-7 Cocoate, Ethanol, Fragrance, Bronopol,

Diisoporpanolamine, Magnesium Nitrate, FD&C Yellow #5, Methychloroisothiazolinone, Magnesium

Chloride, Methylisothiazolinone, FD&C Red #40.

888-GO-BETCO (888-462-3826)

Betco.com

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

Ultra Mild Antibacterial Lotion Skin Cleanser

ULTRA MILD ANTIBACTERIAL SKIN CLEANSER

benzalkonium chloride soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 56 0 1-710

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 LAURYL SULFATE (UNII: 36 8 GB5141J)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

Betco Corporation, Ltd.

GLYCERIN (UNII: PDC6 A3C0 OX)

PEG-4 RAPESEEDAMIDE (UNII: 8 9 575CN9 28 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

CO CO NUT ACID (UNII: 40 U37V50 5D)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

BRO NO PO L (UNII: 6 PU1E16 C9 W)

DIISO PRO PANO LAMINE (UNII: 0 W44HYL8 T5)

MAGNESIUM NITRATE (UNII: 77CBG3UN78 )

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

MAGNESIUM CHLO RIDE (UNII: 0 2F3473H9 O)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 56 0 1-710 -

110 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 7/13/20 17

2

NDC:6 56 0 1-710 -

378 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/13/20 17

3

NDC:6 56 0 1-710 -

20 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 7/13/20 17

0 4/0 1/20 19

4

NDC:6 56 0 1-710 -

9 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 7/13/20 17

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 rt333E

0 7/13/20 17

Labeler -

Betco Corporation, Ltd. (024492831)

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(6 56 0 1-710 ) , label(6 56 0 1-710 ) , pack(6 56 0 1-710 )

Revised: 4/2019

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