Xanitize
FDA Label NDC 77516-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Icm Distributing Company, Inc for the product Xanitize (NDC 77516-111). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from fire or flame

Do Not Use

  • in children less than 2 months of age
  • on open skin wounds

Otc - When Using

When using this product do not use in or near eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. 

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product in your palm to cover hands and rub hands together briskly until dry. 
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store below 110°F (43°C)

Inactive Ingredients

deionized water, glycerin, polysorbate 20, aloe leaf juice, orange peel oil, tocopheryl acetate, maltodextrin, parfum

Package Label - Principal Display Panel

Image Description (Icm Xanitize)

Image Description (Icm Xanitize)

* Please review the disclaimer below.