AMER FRESH- benzalkonium chloride soap

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]

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

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

INGREDIENTS AND APPEARANCE

AMER FRESH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80865-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 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: 80865-001-01	10 g in 1 POUCH; Type 0: Not a Combination Product	11/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/10/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
MRJ'S CROWN INDUSTRIES PRIVATE LIMITED		853186269	manufacture(80865-001)