Active Ingredient
Alcohol: 65% (v/v)
Body Prescriptions Aloha 65 Percent Alcohol Antibacterial Hand Sanitizer
FDA Label NDC 50563-413
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Enchante Accessories Inc. for the product Body Prescriptions Aloha 65 Percent Alcohol Antibacterial Hand Sanitizer (NDC 50563-413). 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, purpose, use, warnings, stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
■ To decrease bacteria on the skin that could cause disease
■Recommended for repeated use
Warnings
For external use only
Flammable. Keep away from heat or flame
Do not use
in children less than two months of age
on open skin wounds
When using this product, keep out of eyes, ears, and mouth
In case of contact with eyes, rinse eyes thoroughly with water
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 control center right away at 1-800-222-1222
Directions
Wet hands thoroughly with product and allow to dry without wiping
For children under 6, use only under adult supervision
Not recommended for infants
Other Information
Do not store above 105F
May discolor some fabrics
Harmful to wood finishes and plastics
Not tested on animals
For adult use only
Inactive Ingredients
Blue 1, Carbomer, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Triehtanolamine, Water, Yellow 5
Package Label.Principal Display Panel
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