FDA.reportPublic FDA data

Band Aid Antiseptic Cleansing

Manufacturer
Kenvue Brands LLC
Effective date
2025-06-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:07:56

Label at a glance#

ProductBand Aid Antiseptic Cleansing
Active ingredientPRAMOXINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure11 sections

Storage and handling

protect from freezing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Benzalkonium Cl (0.13%)

Pramoxine HCl (1.0%)

OTC - PURPOSE SECTION

Purposes

First aid antiseptic

Topical analgesic

Use

INDICATIONS & USAGE SECTION

Uses

first aid to help prevent infection

and temporarily relieve pain or discomfort in minor:

•cuts •scrapes •burns

Warnings

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

Do not use

· in the eyes • over large areas of the body

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • deep or puncture wounds · animal bites
  • serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition or symptoms get worse or last more than 1 week
  • symptoms clear up and occur again within a few days

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 2 years of age and older:
  • clean the affected area
  • spray 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
  • children under 2 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Disodium EDTA

Questions?

OTC - QUESTIONS SECTION

call 800-526-3967 or 215-273-8755 (collect).

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 237 mL Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BAND-AID®

BRAND OF FIRST AID PRODUCTS

ANTISEPTIC

CLEANSING

SPRAY

FIRST AID ANTISEPTIC

PAIN RELEIVING SPRAY

MAX PAIN RELIEF

Kills 99.99% of germs*

to prevent infection

No sting

For minor cuts, scrapes & burns

8 FL OZ (237mL)

Band-Aid_1Band-Aid_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049123benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SprayPSN4
1049123benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD4
1049123benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical SpraySY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0729-8Band Aid Antiseptic Cleansing237 mL in 1 BOTTLE, SPRAYSPRAY2374

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-072969968-0729-8

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
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd55e6b09-0587-61a9-e053-2995a90afaf52025-06-05WarningsExact identifier
ndc (package): 69968-0729-8
ndc (product): 69968-0729
ndc11 (package): 69968072908
spl id: 36ce6da3-4d8a-efe5-e063-6294a90a76ef
spl set id: d55e6b09-0587-61a9-e053-2995a90afaf5

Reported adverse events (FAERS/openFDA)#

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