North First Aid Antiseptic
FDA Label NDC 0498-0015

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by North Safety Products for the product North First Aid Antiseptic (NDC 0498-0015). 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 otc - active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of the reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Benzethonium chloride 0.02% w/w

Benzocaine 10% w/w

Purpose

Topical antiseptic

Topical anesthetic

Uses

for temporary relief of pain and itching and helps protect against infection in:

  • minor cuts and scrapes
  • insect bites
  • minor skin irritations

Warnings

For external use only

Flammable

  • keep away from fire or flame
  • contents under pressure
  • do not puncture or incinerate container
  • do not expose to temperatures above 120o F

Do Not Use

  • in or near the eyes or other mucus membranes
  • in case of serious burns
  • in case of deep or puncture wounds
  • for prolonged period of time
  • on large portion of the body

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days
  • condition clears up and recurs within a few days
  • redness, swelling or irritation occurs

Keep Out Of The Reach Of Children

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

Directions

  • clean the affected area
  • shake can well before using
  • hold 4 - 6 inches from surface and spray area until wet
  • may be covered with a sterile bandage, if bandaged let dry first
  • for adult institutional use only
  • not intended for use on children

Other Information

  • avoid inhaling
  • use only as directed
  • intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal

Inactive Ingredients

dipropylene glycol, isobutane, n-butane, propane

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