AMERFRESH ANTIBACTERIAL- benzethonium chloride soap

AMERFRESH Antibacterial by

Drug Labeling and Warnings

AMERFRESH Antibacterial by is a Otc medication manufactured, distributed, or labeled by Yangzhou Tracey Daily Chemical Plastic Co., Ltd., Yangzhou Tracey Daily Chemical Plastic Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzethonium Chloride 0.1%

Purpose

Antibacterial

Uses

For washing to decrease bacteria on skin.

Warnings

For External Use Only.

WHEN USING

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

DO NOT USE

Do not use this product on infants under 6.

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

Soap (Sodium Palmate and/or Sodiun Tallowate. Sodium Cocoate and/or Sodium Palm Kernelate) Water, Palm Acid, Glycerin, Sodium Chloride, Coconut Acid,Fragrance, Tetrasodium EDTA, Citric Acid Anhydrous.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMERFRESH ANTIBACTERIAL 
benzethonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73343-004
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PALMATE (UNII: S0A6004K3Z)
COCONUT ACID (UNII: 40U37V505D)
PALM ACID (UNII: B6G0Y5Z616)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73343-004-01	1 in 1 CASE	08/15/2020
1		85 g in 1 APPLICATOR; 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	part333E	08/15/2020

Labeler - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Tracey Daily Chemical Plastic Co Ltd		560398069	manufacture(73343-004)