Otc - Active Ingredient
Active Ingredient: Ethyl Alcohol 62%
Anti-bacterial Hand Gel
FDA Label NDC 70483-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jean Pierre Inc. for the product Anti-bacterial Hand Gel (NDC 70483-001). 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, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose Antiseptic
Warnings
Warnings: For external use only. Flammable. Keep away from fire or flame. Do not apply around eyes. Do not use in ears or mouth. When using this product, avoid contact with eyes. In case of contact, flush eyes with water.
Otc - Stop Use
Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Children must be supervised in use of this product.
Dosage & Administration
Directions: Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.
Inactive Ingredient
Inactive ingredients: Water, Aloe Barbadenis Leaf, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, FD&C Yellow No.5
Indications & Usage
Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use
Other Information
Do not store in temperature over 118 F.
Package Label.Principal Display Panel
Image Of Bottle Label (103137)
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