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Band Aid Antiseptic Cleansing Liquid

Band Aid Antiseptic Cleansing Liquid

Approved
Approval ID

d2a6e0d2-5b9b-11c0-e053-2a95a90a4df0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 26, 2025

Manufacturers
FDA

Kenvue Brands LLC

DUNS: 118772437

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzalkonium Chloride and Lidocaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69968-0730
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride and Lidocaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 26, 2025
FDA Product Classification

INGREDIENTS (8)

ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 1.3 mg in 1 mL
Code: F5UM2KM3W7
Classification: ACTIB
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/26/2025

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

BAND-AID**®**
BRAND OF FIRST AID PRODUCTS

ANTISEPTIC

CLEANSING

LIQUID
FIST AID ANTISEPTIC

PAIN RELIEVING LIQUID

Kills 99.99% of germs*

to prevent infection

No sting

Relieves pain

with lidocaine

For minor cuts,
** scrapes & burns**

6 FL OZ (177 mL)

Band Aid_1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/3/2022

Uses

first aid to help prevent infection and temporarily relieve pain or discomfort in minor:

  • cuts
  • scrapes
  • burns

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/26/2025

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/3/2022

Benzalkonium Cl (0.13%)

Lidocaine HCl (2%)

Benzalkonium Cl -
First aid antiseptic

Lidocaine HCl - Topical analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 1/3/2022

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • in large quantities, particularly over raw surfaces or blistered areas.

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

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

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/3/2022

Directions

  • adults and children 2 years of age and older:
    • 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
  • children under 2 years of age: consult a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/3/2022

Other information

  • store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/3/2022

Inactive ingredients

Water, Poloxamer 188, Sodium Chloride, Disodium EDTA, Sodium Citrate, Aloe Barbadensis Leaf Juice

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/3/2022

Questions?

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

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