Active Ingredient[S]
Alcohol 80% v/v
Essentials By Catalina Hand Sanitizer Gel
FDA Label NDC 76902-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Maki Creations for the product Essentials By Catalina Hand Sanitizer Gel (NDC 76902-027). 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[s], purpose, uses[s], warnings, do not use, otc - when using, otc - stop use, otc - 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[S]
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. Flammable. Keep away from heat or flame.
Do Not Use
- on children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison 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)
Inactive Ingredients
Deionized Water, Glycerin, Propylene Glycol, Organic Aloe Barbadensis (Aloe Vera) Leaf Extract, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E Acetate), Carbomer, Aminomethyl Propanol
Package Label.Principal Display Panel
Hand Sanitizer Gel Pail (5 Gallons) (76902 027 03)
Hand Sanitizer Gel Drum (55 Gallons) (76902 027 04)
Hand Sanitizer Gel Tank (tote) (76902 027 05)
Hand Sanitizer Gel 8oz (76902 027 01)
Hand Sanitizer Gel Gallon (76902 027 02)
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