Otc - Active Ingredient
Ethyl alcohol 75% v/v
Hand Sanitizer
FDA Label NDC 78100-300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Corporativo Industrial Bioclean, S.a. De C.v. for the product Hand Sanitizer (NDC 78100-300). 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
Indications & Usage
Hand Sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from fire or flame.
Otc - When Using
When using this product keep out of eyes. In case of contact with eyes, flush 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. Condition 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 and rub into skin until dry.
Children under 6 years of age should be supervised when using this product.
Other Safety Information
Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics.
Inactive Ingredient
Water, Triethanolamine, Glycerine, Carbomer and Methylchloroisothiazolinone/Methylisothiazolinone Mixture
Otc - Questions
Questions? Call +52-331-593-0253
Package Label.Principal Display Panel
WAB GEL 2L NDC: 78100-300-10
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