Otc - Active Ingredient
Alcohol 75% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 55450-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou Shengmei Biotechnology Co., Ltd. for the product Hand Sanitizer (NDC 55450-004). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic, Hand Sanitizer
Indications & Usage
Hand sanitizer to help reduce bacteria on the skin. Recommend for repeated use. For use when soap and water are not available.
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
Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
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 sallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product.
Other Safety Information
Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F).
This product can effectively kill 99.99% Escherichia coli, Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa under experimental conditions. The results are for reference only.
Inactive Ingredient
Aqua, Hydrolyzed Jojoba Esters, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine ,Aloe Barbadensis Leaf Juice Powder, Citric Acid
Package Label.Principal Display Panel
55450-004-01 500mL
Pdp (55450 004 01)
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