Otc - Active Ingredient
Active Ingredient
Ethyl Alcohol 62.0%
Instant Hand Sanitizer Gel
FDA Label NDC 57337-084
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International Corp. for the product Instant Hand Sanitizer (NDC 57337-084). 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, otc - keep out of reach of children, dosage & administration, indications & usage, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antimicrobial
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.
Dosage & Administration
Directions
- wet hands thoroughly with product
- briskly rub hands together until dry
- supervise children under 6 years in the use of this product
Indications & Usage
Use:
- for handwashing to decrease bacteria on the skin
- recommended for repeated use
Warnings
Warnings:
For external use only.
Flammable. Keep away from heat and flame.
Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
Inactive Ingredient
Inactive Ingredients: water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate (Vitamin E), d&c red no. 33
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