FDA.reportPublic FDA data

NOxyDERM

Manufacturer
NOxy Health Products
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:52:23

Label at a glance#

ProductNOxyDERM
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
Benzalkonium Chloride 0.13%First Aid Antiseptic

Purpose

OTC - PURPOSE SECTION

Purpose

First aid antiseptic

Uses: first aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Do not use

OTC - DO NOT USE SECTION

Do not use

  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

  • deep or pucture wounds, animal bites, or serious burns

Warnings For external use only

OTC - WHEN USING SECTION

Warnings

For external use only

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 Poison Control right away

Instructions for use

INSTRUCTIONS FOR USE SECTION

Directions

  • Clean the affected area
  • Apply a small amount of this product on the area 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

Other safety information

Store at room temperature

Dosage

DOSAGE & ADMINISTRATION SECTION

  • Apply a small amount of this product on the area 1 to 3 times daily

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium Nitrite

CoCo Betaine

Deionized Water

Citric Acid

INDICATIONS & USAGE SECTION

Directions:

  • Clean the affected area
  • Apply a small amount of this product on the area 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

Warnings

WARNINGS SECTION

Warnings:

For external use only

Questions

OTC - QUESTIONS SECTION

Questions? call 1-888-585-4120

NOxyDERM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC83823-001-01NDC83823-001-01NDC83823-001-01 Front LabelNDC83823-001-01 Front Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN2
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD2
1020365benzalkonium chloride 0.13 % Topical FoamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
70dd82cf-c501-052d-5d98-d42ef9849750Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83823-001-012026-01-09C16284748780-12cef2736-8ff4-d83d-e063-dadaa90ab31f063a1e99-dda6-9cb9-e063-6294a90aa1b3
83823-001-012026-01-09C16284748780-12cef2736-8ff4-d83d-e063-dadaa90ab31f063a1e99-dda6-9cb9-e063-6294a90aa1b3
83823-001-012025-01-30C16284748780-12cef2736-8ff4-d83d-e063-dadaa90ab31f063a1e99-dda6-9cb9-e063-6294a90aa1b3
83823-001-012025-01-30C16284748780-12cef2736-8ff4-d83d-e063-dadaa90ab31f063a1e99-dda6-9cb9-e063-6294a90aa1b3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83823-001-01NOxyDERM100 mL in 1 BOTTLE, PUMPLIQUID1002

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83823-00183823-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCO-BETAINE03DH2IZ3FYIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM NITRITEM0KG633D4FIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12023-11-27full-release2026-06-01 00:06:37

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
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products063a1e99-dda6-9cb9-e063-6294a90aa1b32026-01-09WarningsExact identifier
ndc (package): 83823-001-01
ndc (product): 83823-001
ndc11 (package): 83823000101
spl id: 47fba953-9744-c751-e063-6394a90a7cca
spl set id: 063a1e99-dda6-9cb9-e063-6294a90aa1b3

Reported adverse events (FAERS/openFDA)#

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