Otc - Active Ingredient
Ethyl Alcohol 75%
Hand Sanitizer
FDA Label NDC 81011-128
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Design Element Group Inc for the product Hand Sanitizer (NDC 81011-128). 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 - ask doctor/pharmacist, otc - do not use, otc - keep out of reach of children, otc - purpose, otc - stop use, otc - when using, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor/Pharmacist
Stop use and ask a doctor if irritation or redness develops & condition persists for more than 72 hours.
Otc - Do Not Use
Do no apply around eyes.
When using this product avoid contact with eyes. In case of contact flush eyes with water.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Children must be supervised in use of this product.
Otc - Purpose
Helps decrease bacteria on skin.
Recommended for repeated use.
Otc - Stop Use
Stop use and ask a doctor if irriation or redness develops & condition persists for more than 72 hours.
Otc - When Using
When using this product avoid contact with eyes. In case of contact flush eyes with water.
Other Safety Information
Store at 20 C( 68-77 F)
May discolor fabrics
Storage And Handling
Store at 20 C (68-77F)
Inactive Ingredient
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzophenone-4, Fragrance Glycerin, Tocopheryl Acetate
Warnings
For external use only.
Flammable. Keep away from fire or flame.
Do not apply around eyes.
Instructions For Use
Pump as needed into your palms & thoroughly spread on both hands.
Dosage & Administration
Active 75% ethyl alcohol
Indications & Usage
Help decrease bacteria on skin.
Pump as needed into your palms & thoroughly spread on both hands.
Hand Sanitizer Gel
75% active ethyl alcohol
inactive ingredients
acrylate crosspolymer
benzophenone-4
fragrance glycerin
tocopheryl acetate
Package Label.Principal Display Panel
Carton Packaging (Img 8134)
Hand sanitizer with added moisturiser
Feeling clean and smooth
* Please review the disclaimer below.
