Otc - Active Ingredient
Ethyl Alcohol 70% v/v
Hand Sanitizer
FDA Label NDC 75668-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Risan Cosmetics S.a. De C.v. for the product Hand Sanitizer (NDC 75668-200). 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.
Warnings
For external use only. Flammable. Keep away from fire or flame.
Otc - When Using
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
and ask a doctor if irritation or rash occurs.
- Condition persists for more than 72 hours.
Otc - 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, Carbomer, Triethanolamine.
Otc - Questions
Call: Risan Cosmetics +52 462 606 6070
Manufactured by Risan Cosmetics S.A. de C.V. Victorino de las Fuentes 487 Col. Barrio Nuevo P.C. 36530 Irapuato, Guanajuato, Mexico. Made in Mexico.
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