Otc - Active Ingredient
Active Ingredient:
Ethyl Alcohol 62%
Anti-bacterial Hand Sanitizer
FDA Label NDC 53603-1021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bb17, Llc for the product Anti-bacterial Hand Sanitizer (NDC 53603-1021). 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 otc - active ingredient, otc - purpose, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:
Antimicrobial
Warnings
WARNING:
FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.
FOR EXTERNAL USE ONLY.DO NOT USE IN THE EYES.
Otc - Stop Use
DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP.
IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR OR PHYSICIAN.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Dosage & Administration
Directions:
Rub into hands until dry.
Inactive Ingredient
Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, D&C Red NO.33.
Storage And Handling
Other Information:
Store below 110 F.
Indications & Usage
KILLS MORE THAN 99.99% OF COMMON GERMS
Package Label.Principal Display Panel
Image Of Bottle Label (Label 1sc)
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