AMERFRESH ANTIBACTERIAL UNWRAPPED by MRJ'S CROWN INDUSTRIES PRIVATE LIMITED

AMERFRESH ANTIBACTERIAL UNWRAPPED by

Drug Labeling and Warnings

AMERFRESH ANTIBACTERIAL UNWRAPPED by is a Otc medication manufactured, distributed, or labeled by MRJ'S CROWN INDUSTRIES PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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%

Purpose

Antibacterial

Use

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80865-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.068 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PALMITATE (UNII: JQ43KP6296)
PALM KERNEL OIL (UNII: B0S90M0233)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80865-002-01	200 in 1 CARTON	11/19/2020
1		10 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/19/2020

Labeler - MRJ'S CROWN INDUSTRIES PRIVATE LIMITED (853186269)

Establishment
Name	Address	ID/FEI	Business Operations
MRJ'S CROWN INDUSTRIES PRIVATE LIMITED		853186269	manufacture(80865-002)

Revised: 9/2022

Document Id: f1f93148-3f3c-4102-b94c-6ac2eaec7f67

34390-5

Set id: f12c51c5-3df9-4972-b3e5-749218cc295c

Version: 2

Effective Time: 20220901