Otc - Active Ingredient
ACTIVE INGREDIENT
Ethyl Alcohol 75%
Hand Sanitizer
FDA Label NDC 78869-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by High 5 Hands Llc for the product Hand Sanitizer (NDC 78869-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
USES
Decreases bacteria on hands.
Warnings
WARNINGS
For external use only. Flammable. Keep away
from fire or flame. Avoid contact with broken skin.
Otc - Do Not Use
Do not use in or near the eyes. In case of contact, flush thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help.
Dosage & Administration
DIRECTIONS
Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised. Not recommended for infants.
Storage And Handling
OTHER INFORMATION
Do not store above 110°F. May discolor some fabrics.
Inactive Ingredient
INACTIVE INGREDIENTS
Acrylate/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl propanol,
Denatonium benzoate, Fragrance (Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water (Aqua)
Package Label.Principal Display Panel
Image Of Bottle Label (2oz)
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