Promedic
FDA Label NDC 79134-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Perfect Medics, Inc for the product Promedic (NDC 79134-001). 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 active ingredients, purpose, warnings, uses, directions, keep out of reach of children., other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzalkonium chloride 0.13%.

Purpose

Antiseptic

Warnings


For external use only.

When using the product

  • Keep out of eyes, in case of contact with eyes, flush thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest

    • Stop use and ask a doctor if skin irritation develops.

Uses

  • to decrease bacteria on the skin that could cause disease.

Directions

  • Wipe down surface thoroughly and allow to air-dry.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

Keep Out Of Reach Of Children.

  • If swallowed, get medical help or contact a poison control center right away.

Other Information

  • do not store above 105F.

Inactive Ingredients

Purified water, glycerin, phenoxyethanol, polysorbate 20 (Polyoxyethylene (20) sorbitan monolaurate), aloe vera leaf juice.

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