Active Ingredient
Ethyl alcohol v/v- 60-80%
Hand Sanitizer
FDA Label NDC 80535-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacia San Arcangel, S.a. De C.v. for the product Hand Sanitizer (NDC 80535-0001). 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, purposes, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antimicrobial
Uses
Hand sanitizer to decrease bacteria on the skin that could cause disease
Recommended for repetead use
Warnings
For external use only: hands
Flammable, keep away form fire and flame
When Using This Product
keep out of ayes, do not use in or near the eyes
In case of contact with eyes, flush thorougly with water
Avoid contact with broken skin
Do not inhale or ingest
keep out of ayes, do not use in or near the eyes
In case of contact with eyes, flush thorougly with water
Avoid contact with broken skin
Do not inhale or ingest
Stop Use And Ask A Doctor If
Irritation and redness develop
Condition persists for more than 72 hours
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a poison center right away
Directions
Put enough product in your palm to cover hands and rub hands together briskly until dry without wiping
for children under 6 years of age should be supervised when using
not recommended for infants
Other Information
Store below 105 F 40C
Mary discolour certain fabrics
harmful to wood finishes and plastics
Inactive Ingredients
Purified water (aqua), vegetable glycerin, carboxymethyl cellulose, hydroxypropyl methylcellulose HPMC, and pepper mint oild and vitamine E
Principal Display
Natural ingredients
Mint
Hand sanitizer gel
eliminates 99.9% of germs
vitamine E hands soft
contain mosturizers
*e coli and S. areus
HO3
parabens
methanol
formaldehyde
triethanolamine
carbopol
free
* Please review the disclaimer below.
