Hand Sanitizer
FDA Label NDC 78915-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tv Direct Llc for the product Hand Sanitizer (NDC 78915-001). 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 drug facts, active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor, 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 75% v/v

Purpose

Antiseptic

Uses:

Hand Sanitizer to help reduce bacteria on the skin

Warnings:

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

Do Not Use

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

When Using This Product

keep out of eyes, ears, and mouth. In case of contact with eyes, 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.

Directions:

  • Place enough product on hands to cover all surfaces. Rubs hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information:

  • Store between 15-30°C (59-86°F)
  • May discolor fabrics
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients:

Aqua, Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract

Package Labeling:1000Ml

Box (Box)

Box (Box)

Package Labeling:60Ml

Box2 (Box2)

Box2 (Box2)

* Please review the disclaimer below.