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:
Demoulas Super Markets, Inc
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:
53942-403-68, 53942-403-96

HAND WASH- benzalkonium chloride liquid

Demoulas Super Markets, Inc

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.

----------

Market Basket 403.002/403AC

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, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride,

myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid,

tetrasodium EDTA, benzophenone-4, sodium benzoate, red 4, yellow 5

Adverse reactions

DISTRIBUTED BY DEMOLAS SUPER MARKETS, INC.

875 EAST STREET, TEWKSBURY, MA 01876

403.002/403AC

principal display panel

MORE FOR YOUR DOLLAR

MARKET BASKET

ANTIBACTERIAL

LIQUIE HAND SOAP

7.5 FL OZ (221 mL)

HAND WASH

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:539 42-40 3

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)

LAURAMINE O XIDE (UNII: 4F6 FC4MI8 W)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

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

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

DISTEARETH-7 5 ISO PHO RO NE DIISO CYANATE (UNII: 536 5FJ30 SC)

PEG-150 DISTEARATE (UNII: 6 F36 Q0 I0 AC)

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 RED NO . 4 (UNII: X3W0 AM1JLX)

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

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:539 42-40 3-

16 56 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /28 /20 14

2

NDC:539 42-40 3-

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

0 8 /28 /20 14

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 8 /28 /20 14

Labeler -

Demoulas Super Markets, Inc (007869647)

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 (539 42-40 3)

Demoulas Super Markets, Inc

Revised: 5/2020

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