Active Ingredient(S)
Ethyl Alcohol 75%
Hand Sanitizer
FDA Label NDC 79054-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trinine Wellness Llc for the product Hand Sanitizer (NDC 79054-002). 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, 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
Antimicrobial
Use
Hand sanitizer to help reduce germs on skin that could cause disease.
Recommended for repeated use.
Warnings
For external use only: hands.Flammable. Keep away from heat, fire, or flame.
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, rash, or redness develops and lasts.
Keep out of reach for children. If swallowed, get medical help or contact a
Poison Control Center right away.
Do Not Use
/
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, rash, or redness develops and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach for 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.
Other Information
Store below 106°F. (41 °C).
May discolor certain fabrics or surfaces.
Inactive Ingredients
Water, Carbomer (Gel), Melaleuca Oil (Tea Tree Oil), Aloe Barbadensis Leaf Extract
(Aloe), Tocopherols (Vitamin E),Triethaolamine (Tea)
Label
60 (60ml)
50 (50ml)
120 (120ml)
236 (236ml)
500 (500ml)
1000 (1000ml)
3785 (3785ml)
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