Antiseptic
FDA Label NDC 51532-5300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Afassco Inc. for the product Antiseptic (NDC 51532-5300). 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 ingredients, purpose, uses, warnings, do not use, otc - keep out of reach of children, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Purpose

First Aid Antiseptic

Topical Pain Relief

Uses

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Warnings

For external use only.
Flammable keep away from fire or flame.

Do Not Use

  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • more than one week unless directed by a doctor

Otc - Keep Out Of Reach Of Children

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

Otc - Stop Use

Stop use and ask doctor if condition persists or gets worse

Directions

  • clean affected area and spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 ask a doctor.

Inactive Ingredients

isopropyl alcohol, purified water

Principal Display Panel – Bottle Label

First Aid
Antiseptic
Spray

Aids in Preventing Infections

  • Temporary Pain Relief
  • Fights Infection
  • Promotes Healing

    • #623 2 Fl. Oz. (59 mL)

    Mfd. For
    Afassco
    MINDEN, NV 89423

    Principal Display Panel – Bottle Label (Afa00 0001 01)

    Principal Display Panel – Bottle Label (Afa00 0001 01)

* Please review the disclaimer below.