Otc - Active Ingredient
Active ingredient: Ethyl alcohol 62%.
5406 Hand Sanitizer Gel
FDA Label NDC 76138-116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Innovation Specialties for the product 5406 Hand Sanitizer (NDC 76138-116). 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 - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, 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
For handwashing to decrease bacteria on the skin.
Warnings
Warnings: Flammable, keep away from fire or flame. For external use only.
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 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 right away.
Dosage & Administration
Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.
Inactive Ingredient
Inactive ingredients: Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.
Otc - Questions
Questions? HOTLINE # 1-855-755 5346 NPN# 80062390
Storage And Handling
Store at room temperature 15° to 30°C (59° to 86°F).
Other
Made in China For Innovation Line Los Angeles,
CA 90066 Product # 5406
Packaging
Image Description (Label 1)
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