HAND WASH- benzalkonium chloride liquid

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
OLD EAST MAIN CO.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antibacterial for handwashing to decrease bacteria on the skin - irritation or redness develops - condition persists for more than 72 hours
Authorization status:
OTC monograph not final
Authorization number:
55910-628-45, 55910-628-96

HAND WASH- benzalkonium chloride liquid

OLD EAST MAIN CO.

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.

----------

Antibacterial Hand Soap

628.002/628AD-AE

Active ingredient

Benzalkonium chloride 0.13%

purpos e

Antibacterial

Us e

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands only

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops

condition persists for more than 72 hours

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands

apply palmful to hands

scrub thoroughly

rinse thoroughly

Inactive ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine

oxide, glycerin, fragrance, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, blue

1, red 33

OLD EAST MAIN C0

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% SATISFATION GUARANTEED (888)309-9030

PRINCIPAL DISPLAY PANEL

DG|body

Antibacterial

Foaming

Hand Soap

Refill

Fresh Spring

32 FL OZ (1 QT) 946 mL

PRINCIPAL DISPLAY PANEL

Studio Selection

Antibacterial foaming hand soap

Helps kill harmul germs

Fresh spring

7.5 FL OZ (221 mL)

HAND WASH

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:559 10 -6 28

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

OLD EAST MAIN CO.

WATER (UNII: 0 59 QF0 KO0 R)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

LAURAMIDO PRO PYLAMINE O XIDE (UNII: I6 KX16 0 QTV)

LAURAMINE O XIDE (UNII: 4F6 FC4MI8 W)

MYRISTAMIDO PRO PYLAMINE O XIDE (UNII: 3HSF539 C9 T)

GLYCERIN (UNII: PDC6 A3C0 OX)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

SULISO BENZO NE (UNII: 1W6 L6 29 B4K)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:559 10 -6 28 -

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

Pro duc t

0 2/0 6 /20 20

2

NDC:559 10 -6 28 -

9 46 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/17/20 16

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

0 2/17/20 16

Labeler -

OLD EAST MAIN CO. (068331990)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

0 8 8 520 6 6 8

ma nufa c ture (559 10 -6 28 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

79 0 752542

ma nufa c ture (559 10 -6 28 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

150 9 31459

ma nufa c ture (559 10 -6 28 )

Revised: 5/2020

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