Active Ingredient(S)
Ethyl Alcohol 70%
Hand Sanitizer
FDA Label NDC 61354-044
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development Llc for the product Hand Sanitizer (NDC 61354-044). 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, use, warnings, when using, stop use, 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
Purpose
Antimicrobial
Use
Hand Sanitizer to help reduce bacteria on the skin.
Warnings
Flammable. Keep away from heat or flame. For external use only.
When Using
When using this product do not use in or near the eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Put enough product in your palm to cover hands and rub hands together until dry.
- Children under 6 years of age should be supervised when using this product.
Other Information
- Store below 110F (43C)
- May discolor certain fabric surfaces.
Inactive Ingredients
Water / aqua, Glycerin, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice.
Package Label - Principal Display Panel
61354-044-01_aw (Art 050 Lbl Wrp 149)
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