Promedic
FDA Label NDC 79134-003

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 79134-003). 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

Ethyl alcohol 75%.

Purpose

Antiseptic

Warnings

For external use only - hands.

Flammable, keep away from heat and flame.

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.
  • recommended for repeated use.

Directions

  • Wet hand thoroughly and allow to dry without wiping.
  • 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.
  • may discolor some fabrics.
  • harmful to wood finish and plastics.

Inactive Ingredients

Purified water, Glycerin, Carbomer (Decanoic acid, 1-methyl-1,2-ethanediyl ester mixed with 1-methyl-1,2-ethanediyl dioctanoate) , aloe barbadensis leaf juice, fragrance, triethanolamine

Label 238Ml

Image Description (238ml)

Image Description (238ml)

474Ml

Image Description (464ml)

Image Description (464ml)

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