Instant Hand Sanitizer Gel
FDA Label NDC 53598-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bonita Pharmaceuticals Llc for the product Instant Hand Sanitizer Gel (NDC 53598-007). 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 drug facts, purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, direction, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

  • To help decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings

For external use only. Flammable, keep away from fire or flame.

Otc - Do Not Use

  • Keep out of eyes. In case of eye contact, flush it thoroughly with water, seek medical attention immediately.
  • Avoid contact with broken skin.

Otc - Stop Use

  • Stop use and ask a doctor if redness or Irritation develops and persists for more than 72hrs.

Otc - Keep Out Of Reach Of Children

  • Keep away from children. If swallowed, seek medical attention immediately. Children must only use this product under adult supervision.

Direction

  • Place small amount of Bonita sanitizer in your palm. Thoroughly spread on both hands and rub together until dry.

Other Information

  • Store below 105 ˚F.
  • May discolor some fabrics.

Inactive Ingredients

  • Water
  • Propylene glycol
  • Isopropyl alcohol
  • PEG-12
  • Carbomer 940
  • Fragrance
  • Triethanolamine

* Please review the disclaimer below.