Prime
FDA Label NDC 79382-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prime Industries Usa, Inc for the product Prime (NDC 79382-001). 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 ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, 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 Ingredient

Ethyl Alcohol 75% v/v.

Purpose

Antiseptic

Uses

  • Hand sanitizer to help decrease bacteria on the skin.
  • When water, soap & towel are not available.
  • Recommended for repealed use.

Warnings

  • For external use only
  • Flammable. Keep away from fire or flame.
  • Do not apply around eyes. Do not use in ears & mouth.
  • When using this product avoid contact with eyes.
  • In case of contact flush eyes with water.
  • Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Children must be supervised in use of this product.

Directions

  • Pump as needed into your palms and thoroughly spread on both hand.
  • Rub into skin until dry.

Other Information

  • Store at 20oC (88-77oF).
  • May discolor fabrics.

Inactive Ingredients

Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine.

Package Label - Principal Display Panel

60 mL

100 mL

237 mL

500 mL

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