Amber and Black

Manufacturer
NV Labs
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:45

Label at a glance#

ProductAmber and Black
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

For handwashing to decrease bacteria of the skin

Dosage and administration

Directions Apply to Dry Hands Lather vigorously for at least 15 seconds Rinse and dry throughly

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Benzalkonium Chloride 0.13% v Antibacterial

USES

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria of the skin

WARNING

WARNINGS SECTION

Warnings

For External Use only

When using this product

Avoid Contact with eyes

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation orredness develops.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply to Dry Hands
  • Lather vigorously for at least 15 seconds
  • Rinse and dry throughly

In active Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua) , Lauramidopopylamine Oxide, cocamidopropyl Betaine, lauramine Oxide, Sodium Chloride, Glycerin, Myristamine Oxide, Cetrimonium Chloride, Fragrance, PEG-120 Methy Glucose Dioleate, PEG-150 Distearate, Citric Acid, Tetrasodium EDTA, Sodium Benzoate, RED 40, Red 33, Yellow 5.

Manufactured By: Questions or Comments

OTC - QUESTIONS SECTION

Manufactured By: Reforma Group, Southfield, Michigan 48033

Questions or comments? Call 1-248-358-9022

Keep out of Reach of Children

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.

Purpose

OTC - PURPOSE SECTION

Antbacterial

Package Label Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti bacterial SoapAnti bacterial Soap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73696-104-162024-01-30C16284748780-11030e365-2833-111a-e063-dadaa90a10e2Amber and Black Antibacterial Hand Soap (16 Fl. Oz .)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73696-104-16Amber and Black473 g in 1 BOTTLE, PLASTICSOAP4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73696-104AMBER AND BLACK (BENZALKONIUM CHLORIDE) SOAP [NV LABS]2Legacy NDC, 1 package rows20220114_a470baf8-dbb6-a7a2-e053-2a95a90a97ea.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73696-10473696-104-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML · Source PDF

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
d5788ee8-49fb-1bcb-e053-2a95a90a7f84a470baf8-dbb6-a7a2-e053-2a95a90a97ea2022-01-13WarningsExact identifier
spl id: d5788ee8-49fb-1bcb-e053-2a95a90a7f84
spl set id: a470baf8-dbb6-a7a2-e053-2a95a90a97ea

Reported adverse events (FAERS/openFDA)#

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