Hand Gel Prolim Instant Hand Sanitizer
FDA Label NDC 50414-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prolim Quimica Avancada Ltda. for the product Hand Gel Prolim Instant Hand Sanitizer (NDC 50414-100). 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, when using this product, otc - stop use, keep out of reach of children, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

  • Recommended for aseptic hand cleansing. This product does not replace the use of soap and water.
  • Recommended for repeated use.

Warnings

For external use only

When Using This Product

  • Keep out of eyes. In case of accidental contact, flush eyes thoroughly with water for 15 minutes.
  • Avoid contact with broken skin or you have allergies to any ingredients.

Otc - Stop Use

Stop use and consult a doctor if skin irritation occurs.

Keep Out Of Reach Of Children

  • In case of accidental ingestion drink plenty of water and seek medical help or contact a Poison Controll Center immediately.
  • External use only.

Other

FLAMMABLE: Keep out of heat.

Directions

  • Place a small amount of product in your hand.
  • Rub hands together briskly for at least 30 seconds until dry.
  • Children under 6 years of age should use under adult supervision.

Inactive Ingredients

Water, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol,  Carbomer, DDM Hydantoin, Aminomethyl Propanol, Fragrance.

Questions?

555-555-5555

Principal Display Panel

Image Of Label (bottle)

Image Of Label (bottle)

HAND GEL PROLIM
INSTANT HAND SANITIZER
Kills 99,99% of most commom germs
2.7 OZ FL (80ml)

* Please review the disclaimer below.