Otc - Active Ingredient
Alcohol 75% v/v. Purpose: Antiseptic
Alcohol Hand Sanitizer
FDA Label NDC 55450-005
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 Alcohol Hand Sanitizer (NDC 55450-005). 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.
Warnings
For external use only.
Flammable. Keep away from heat or flame.
Otc - When Using
Keep out of eyes. 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 develop, persisit for more than 72 hours.
Otc - Keep Out Of Reach Of Children
keep out of reach of children. If sallowed, get medical help right away.
Dosage & Administration
Place enough product on hands to cover hands and rub hands quickly until dry. Children under 6 years of age should be supervised when using product.
Other Safety Information
Do not store above 105F (43F). May discolor certain fabrics or surfaces.
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
55450-005-01 100g
Pdp (55450 005 01)
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