Hand Sanitizer
FDA Label NDC 77397-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ammmm, Inc. for the product Hand Sanitizer (NDC 77397-101). 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, function:, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethyl Alcohol 70%

Purpose

ANTIBACTERIAL

Function:

70% ALCOHOL HAND SANITIZERS KILL MOST BACTERIA, AND FUNGI AND STOP SOME VIRUSES, KILL 99.9% OF THE BACTERIA ON HANDS 30 SECONDS AFTER APPLICATION AND 99.99% TO 99.999% IN ONE MINUTE.

Warnings

FOR EXTERNAL USE ONLY

KEEP AWAY FROM HEAT, FIRE OR FLAME.

WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES. IN CASE OF EYE CONTACT, FLUSH WITH THOROUGHLY WATER. AVOID CONTACT WITH BROKEN SKIN.

STOP USE AND ASK A DOCTOR: IF IRRITATION OR REDNESS DEVELOPS OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS.

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

  • APPLY AMOUNT OF SANITIZER IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS
  • RUB HANDS TOGETHER BRISKLY UNTIL DRY
  • NO RINSING REQUIRED
  • FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION AND DON'T ALLOW THEM TO PUT THEIR HANDS IN THEIR MOUTH UNTIL THE PRODUCT EVAPORATES AND FEELS COMPLETELY DRY ON THE SKIN TO AVOID ACCIDENTAL INGESTION
  • NOT RECOMMENDED FOR INFANTS

Inactive Ingredients

AQUA, GLYCERIN, PROPYLENE GLYCOL, CARBOMER, AMINOMETHYL PROPANOL

Package Label.Principal Display Panel

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