Active Ingredient(S)
Ethyl Alcohol 75% v/v. Purpose: Antimicrobial
Instant Hand Sanitizer Gel
FDA Label NDC 78301-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ganzhou Yuanling Medical Technology Co.,ltd for the product Instant Hand Sanitizer Gel (NDC 78301-050). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial, Hand Sanitizer
Use
Hand sanitizer to help reduce bacteria on the skin that could cause disease.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - 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.
Directions
- For children under age 6, use only under adult supervision.
- Put enough product in your palm to wet hands thoroughly and rub briskly untill dry without wiping.
Other Information
- Store below 110℉ (43 ℃)
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Blue 1(CI 42090), Carbomer, Fragrance (Parfum), Glycerin, Triethanolamine, Tocopheryl Acetate, Water(Aqua), Yellow 5 (CI 19140)
Package Label - Principal Display Panel
50 mL NDC: 78301-050-01
100 mL NDC: 78301-050-02
250 mL NDC: 78301-050-05
500 mL NDC: 78301-050-10
1000 mL NDC:78301-050-20
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