AMERFRESH ANTIBACTERIAL UNWRAPPED- 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:
MRJ'S CROWN INDUSTRIES PRIVATE LIMITED
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antibacterial For washing to decrease bacteria on the skin
Authorization status:
OTC monograph not final
Authorization number:
80865-002-01

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AMERFRESH ANTIBACTERIAL UNWRAPPED- benzalkonium chloride soap

MRJ'S CROWN INDUSTRIES PRIVATE LIMITED

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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Active Ingredient

Benzalkonium Chloride 0.1%

Purpos e

Antibacterial

Us e

For washing to decrease bacteria on the skin

Warnings

For external use only.

When using this product avoid contact with eyes .in case of eyes contact ,flush with water

Stop use and doctor ask if irritation and redness develops

Keep out of reach of children if swallowed ,get medical help or contact a Poison control center right

away .

Directions

Wet bar with water

Lather vigorously and wash skin

Rinse and dry thoroughly

Inactive ingredients

Sodium Palmitate

Palm Kernelate

Fragrance

Aqua

Sodium Chloride

Glycerine

Titanium Di Oxide

Tetra Sodium EDTA

Product label

AMERFRESH ANTIBACTERIAL UNWRAPPED

benzalkonium chloride soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 8 6 5-0 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

0 .1 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM PALMITATE (UNII: JQ43KP6 29 6 )

PALM KERNEL O IL (UNII: B0 S9 0 M0 233)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 0 8 6 5-0 0 2-

20 0 in 1 CARTON

11/19 /20 20

1

6 8 g in 1 NOT APPLICABLE; Type 0 : No t a Co mbinatio n

Pro duc t

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

11/19 /20 20

MRJ'S CROWN INDUSTRIES PRIVATE LIMITED

Labeler -

MRJ'S CROWN INDUST RIES PRIVAT E LIMIT ED (853186269)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MRJ'S CROWN INDUSTRIES PRIVATE LIMITED

8 5318 6 26 9

ma nufa c ture (8 0 8 6 5-0 0 2)

Revised: 11/2020

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