PREMIUM ANTIBACTERIAL HAND- 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:
Insolcorp, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antibacterial For washing to decrease bacteria on the skin STOP USE AND ASK A DOCTOR IF irritation and redness develops
Authorization status:
OTC monograph not final
Authorization number:
74811-002-01

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PREMIUM ANTIBACTERIAL HAND- benzalkonium chloride soap

Insolcorp, LLC

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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Premium Antibacterial Hand Soap

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

PURPOSE

Antibacterial

USE

For washing to decrease bacteria on the skin

WARNINGS

For external use only

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. Incase of eye contact flush

with water.

STOP USE AND ASK A DOCTOR IF irritation and redness develops

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, get medical help or contact a

poision control

center right away.

DIRECTIONS

Pump into dry hands and forearms, lather for atleast 15 seconds, rinse and dry.

INACTIVE INGREDIENTS

Water, Caprylyl / Capryl Glucosides, Laurtrimonium Chloride, Cocamidoprpylamine Oxide, Citric

Acid, Fragrance

PRINCIPAL DISPLAY PANEL

PREMIUM ANTIBACTERIAL HAND SOAP

LEMON BLOSSOM

8 FL. OZ. (240 mL)

PREMIUM ANTIBACTERIAL HAND

benzalkonium chloride soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:748 11-0 0 2

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)

DECYL GLUCO SIDE (UNII: Z17H9 7EA6 Y)

LAURTRIMO NIUM CHLO RIDE (UNII: A8 1MSI0 FIC)

CO CAMIDO PRO PYLAMINE O XIDE (UNII: M4SL8 2J7HK)

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

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:748 11-0 0 2-

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

Pro duc t

12/10 /20 20

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

12/10 /20 20

Insolcorp, LLC

Labeler -

Insolcorp, LLC (080539371)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Inso lco rp, LLC

0 8 0 539 371

ma nufa c ture (748 11-0 0 2)

Revised: 12/2020

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