FDA.reportPublic FDA data

Amerfresh Antibacterial Unwrapped

Manufacturer
Jiangsu Aimeili Cosmetic Co.,Ltd.
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:40

Label at a glance#

ProductAmerfresh Antibacterial Unwrapped
Active ingredientBENZETHONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Wet bar with water Lather vigorously and wash skin Rinse and dry thoroughly

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

For washing to decrease bacteria on skin

Warnings

WARNINGS SECTION

For external use only

Do not use this product on infants under 6

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet bar with water

Lather vigorously and wash skin

Rinse and dry thoroughly

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1872091benzethonium chloride 0.1 % Medicated Bar SoapPSN2
1872091benzethonium chloride 0.001 MG/MG Medicated Bar SoapSCD2
1872091benzethonium chloride 0.1 % Medicated Bar SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77573-010-01Amerfresh Antibacterial Unwrapped200 in 1 CARTONSOAP2002
77573-010-01Amerfresh Antibacterial Unwrapped85 g in 1 PACKAGESOAP852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77573-010AMERFRESH ANTIBACTERIAL UNWRAPPED (ALCOHOL) SOAP [JIANGSU AIMEILI COSMETIC CO.,LTD.]2Legacy NDC, 2 package rows20240105_c1ec846c-bdfc-4e1d-820b-a65a272a2691.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77573-01077573-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PALMATES0A6004K3ZIACT
WATER059QF0KO0RIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
PALM ACIDB6G0Y5Z616IACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
COCONUT ACID40U37V505DIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e2cf0e2-402f-541a-e063-6294a90a72efc1ec846c-bdfc-4e1d-820b-a65a272a26912024-01-05WarningsExact identifier
spl id: 0e2cf0e2-402f-541a-e063-6294a90a72ef
spl set id: c1ec846c-bdfc-4e1d-820b-a65a272a2691

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.