AMER FRESH by MRJ'S CROWN INDUSTRIES PRIVATE LIMITED

AMER FRESH by

Drug Labeling and Warnings

AMER FRESH 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]

AMER FRESH- 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

image description

AMER FRESH 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80865-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80865-001-0110 g in 1 POUCH; Type 0: Not a Combination Product11/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/10/2020
Labeler - MRJ'S CROWN INDUSTRIES PRIVATE LIMITED (853186269)
Establishment
NameAddressID/FEIBusiness Operations
MRJ'S CROWN INDUSTRIES PRIVATE LIMITED853186269manufacture(80865-001)

Revised: 11/2020
Document Id: ea04e36e-aca5-4d6e-9502-c9339e1114b2
Set id: bc86c048-bed5-4cf9-b2b1-af67032b4a6f
Version: 1
Effective Time: 20201110