Active Ingredients
Alcohol 70% v/v..................................................................Antiseptic
Antiochpharma Hand Sanitizer Gel
FDA Label NDC 11383-308
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Weeks & Leo for the product Antiochpharma Hand Sanitizer (NDC 11383-308). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only
Do Not Use
in children less than 2 months of ageon 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. Rub 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)
Avoid freezing and excessive heat above 40 °C (104 °F)
Close cap after use
May discolor certain fabrics or surfaces
Inactive Ingredients
acrylates/C10–30 alkyl acrylate crosspolymer, aminomethyl propanol, glycerin, isopropyl myristate, propylene glycol, purified water, SD alcohol 40-B, tocopheryl acetate
Package Label
AntiochPharma
Hand Sanitizer
With Vitamin E and Moisturizers
Kills 99.99 %of germs
made in USA
* Please review the disclaimer below.
