FOAMING HAND- benzalkonium chloride lotion

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Vi-Jon
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - for handwashing to decrease bacteria on the skin - irritation or redness develop - condition persists for more than 72 hours
Authorization status:
OTC monograph not final
Authorization number:
11344-224-04, 11344-224-08, 11344-224-20, 11344-224-44, 11344-224-45, 11344-224-96

FOAMING HAND- benzalkonium chloride lotion

Vi-Jon

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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Germ-X Foaming Hand Soap

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

for handwashing to decrease bacteria on the skin

Warnings

for external use only: hands

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 develop

condition persists for more than 72 hours

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center

immediately.

Directions

wet hands

apply palmful to hands

scrub thoroughly

rinse thoroughly

Inactive ingredients

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

oxide, glycerin, citric acid, tetrasodium EDTA, sodium benzoate

Rear label text

Product is NSF certified for use as a hand sanitizer in and around food processing areas.

Manufactured By: Vi-Jon, Inc.

8515 Page Ave., St. Louis, Mo 63114

vijonprofessional.com

224.000/224AA

Principal display panel

germ-X

Professional

E2 SANITIZING

FORAMING

HAND SOAP

Helps kill harmful germs

Nonfood Compounds

Program Listed (Code E2)

1.5 FL OZ (44 mL)

FOAMING HAND

benzalkonium chloride lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11344-224

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)

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)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:11344-224-

378 5 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 8 /20 18

2

NDC:11344-224-

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

0 2/0 8 /20 18

3

NDC:11344-224-

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

Pro duc t

0 2/0 8 /20 18

4

NDC:11344-224-

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

Pro duc t

0 2/0 8 /20 18

5

NDC:11344-224-

1150 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 8 /20 18

6

NDC:11344-224-

44 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 8 /20 18

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 2/0 8 /20 18

Vi-Jon

Labeler -

Vi-Jon (150931459)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

150 9 31459

ma nufa c ture (11344-224)

Revised: 6/2019

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