Hand Sanitizer
FDA Label NDC 43219-104

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Emilia Cosmetics Ltd for the product Hand Sanitizer (NDC 43219-104). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, 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% V/V

Purpose

ANTIMICROBIAL

Uses

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

Warnings

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM OPEN FIRE OR FLAME.

WHEN USING THIS PRODUCT DO NOT USE NEAR THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH AND LASTS.

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

  • PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS BRISKLY TOGETHER UNTIL DRY.
  • CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.
  • NOT RECOMMENDED FOR INFANTS.

Other Information

  • STORE BELOW 110°F (43°C)
  • MAY DISCOLOR CERTAIN FABRICS OR SURFACE.

Inactive Ingredients

WATER, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, ETHYLHEXYLGLYCERIN, PANTHENOL (PRO-VITAMIN B5), FRAGRANCE.

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