Alcohol (Ethyl Alcohol Or Ethanol)
Ethyl Alcohol at 70% volume by volume
Hand Sanitizer
FDA Label NDC 74128-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tekkware, Inc. D.b.a. Gloucester Bio for the product Hand Sanitizer (NDC 74128-080). 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 alcohol (ethyl alcohol or ethanol), hand sanitizer, inactive ingredients, uses, keep out of reach of children, directions, warnings, 473ml ndc: 74128-070-16, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Hand Sanitizer
OTC Antiseptic Drug Products
Inactive Ingredients
water, glycerin
Uses
Hand sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under six years of age when using this product to avoid swallowing.
Warnings
For external use only. Flammable. Keep away from heat or flame.
- Do not use in children less than 2 months of age. Do not use 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 and ask a doctor if irritation or rash occur. These may be signs of a serious condition.
473Ml Ndc: 74128-070-16
473mL NDC: 74128-070-16
473 mL Label (Gb473)
DrugFacts
946Ml Ndc: 74128-070-32
956mL NDC: 74128-070-32
946 Drug Facts
237Ml Ndc: 74128-070-08
237mL NDC: 74128-070-08
237 Drug Facts
118Ml Ndc: 74128-070-04
118 Label (Gb118)
118 drug facts
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