Biotic-plus
FDA Label NDC 69103-2400

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Provision Medical for the product Biotic-plus (NDC 69103-2400). 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, keep out of reach of children, do not use, stop use, ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

advanced Stops Pain and Prevents Infection for Cuts and Scrapes

BIOTIC-PLUS       0.5g

Active Ingredients

(in each gram)

Bacitracin zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)

Lidocaine .40 mg

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Anesthetic

Uses

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

The Provision First Aid Line

Manufactured for Provision Medical Products Palm Desert, CA 92211

Warnings

For external use only.

Keep Out Of Reach Of Children

If ingested, contact a Poison Control Center directly.

Do Not Use

  • in eyes or over large areas of the body
  • more than 1 week unless directed by a doctor
  • if allergic to ingredients.

Stop Use, Ask A Doctor

  • in case of deep or puncture wounds, animal bites or serious burns
  • if conditions worsen or last more than 7 days
  • if rash or allergic reaction occurs

Directions

  • adults & children 2 years & older: clean affected area, apply amount (equal to surface area of a tip of finger) on area 1-3 times daily. May be covered with a sterile bandage.
  • children under 2: do not use, ask a doctor

Inactive Ingredients

white petrolatum

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