New Skin Bandage Spray
FDA Label NDC 16864-450

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advantice Health, Llc. for the product New Skin Bandage (NDC 16864-450). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by Advantice Health, LLC
Cedar Knolls, NJ 07927

Active Ingredient

Benzethonium chloride 0.2%

Purpose

First aid antiseptic

Use

first aid to help prevent bacterial contamination in minor cuts and scrapes

Warnings

For external use only

Flammable keep away from fire or flame

Do Not Use

  • in the eyes
  • over large areas of the body
  • longer than one week unless directed by a doctor
  • on infected areas or wounds that are draining
  • with other first aid products such as lotions and creams
  • over sutures
  • on mucous membranes

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • deep cuts
  • animal bites
  • serious bleeding
  • diabetes
  • poor circulation
  • serious burns

When Using This Product

  • do not get in eyes
  • do not store at temperatures above 120° F
  • do not puncture or incinerate; contents under pressure
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

Stop Use And Ask A Doctor If

  • condition persists or gets worse
  • infection occurs

Keep Out Of Reach Of Children

If swallowed, get medical help or call a Poison Control Center right away.

Directions

  • clean affected area
  • shake well
  • spray a small amount on the area 1-3 times daily
  • let dry
  • a second coating may be applied for extra protection
  • to remove, apply more New-Skin® Liquid Bandage Spray and quickly wipe off
  • New-Skin® may at times form a thin covering over the spray hole. If valve doesn't spray, simply scratch across spray hole with fingernail

Other Information

  • store at 20-25°C (68-77°F), away from heat
  • may temporarily sting upon application
  • do not allow to come into contact with floors, counter tops or other finished surfaces - will stain

Inactive Ingredients

acetone, amyl acetate, butyl acetate, camphor, ethyl acetate, isobutane, nitrocellulose, propane, SD alcohol 3-C (4.9% v/v)

Questions?

1-800-345-0032
www.NewSkinProducts.com

Principal Display Panel - 28.5 G Canister Box

new-
skin®
Benzethonium Chloride 0.2%/First Aid Antiseptic
LIQUID BANDAGE
SPRAY

ALL-IN-ONE
PROTECTION

Prevents Infection

Seals Out Water,
Dirt & Germs

Helps Heal Cuts

Protects Wounds,
Blisters & Calluses

#1
pharmacist
recommended

NET WT
1 OZ (28.5 g)

Works
Where
Bandages
Can't

Principal Display Panel (28.5 g Canister Box)

Principal Display Panel (28.5 g Canister Box)

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