Otc - Active Ingredient
Active Ingredient
Ethyl Alcohol 70%
Hand Sanitizer
FDA Label NDC 78495-169
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ultra Distributors Inc. for the product Hand Sanitizer (NDC 78495-169). 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 - when using, 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 to decrease bacteria on the skin that could cause disease recommended for repeated use
Warnings
Warnings
for external use only: hands
Flammable. Keep away from fire or flame
Otc - When Using
When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin. do not inhale or ingest.
Otc - Stop Use
Stop use and ask a doctor if . irritation or redness develops. condition persists for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. if swallowed, get medical help or contact a poison control center(1-800-222-1222)right away .
Dosage & Administration
Directions
- wet hands thoroughly with product and allow to dry without wiping.
- for children under 6 , use only under adult supervision.
- not recommented for infants .
Storage And Handling
Other information
- do not store above 105°F
- may discolor some fabics
- harmful to wood finished and plastics
Inactive Ingredient
Inactive ingredients
acrylates/C10-C30 alkyl acrylate crosspolymer,aloe barbadensis leaf juice, aminomethyl propanol, glycerin, maltodextrin, propylene glycol, water , tocopheryl acetate
Package Label.Principal Display Panel
Image Of Bottle Label (16.9oz)
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