Xepi Rub Et Hand Sanitizing Handrub
FDA Label NDC 81357-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanmed Healthcare Private Limited for the product Xepi Rub Et Hand Sanitizing Handrub (NDC 81357-101). 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 drug facts, active ingredients, purpose, uses:, warnings:, otc - keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Ethyl Alcohol 80.0% v/v
Purpose
Antiseptic Handrub
Uses:
* A hand rub to decrease microbial load on the skin
Warnings:
* For external use only
* Flammable. Keep away from fire or flame, heat sparks and sources of static discharge.
When using this product:
* Keep out of Eyes, Ears and Mouth.
* In case of contact with eyes, rinse promptly & thoroughly with water.
* Discontinue use if irritation and redness develop.
Stop use and ask a doctor if skin irritation or redness occurs 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.
Directions:
* Apply product onto hands, spread thoroughly & rub until dry.
Other Information:
* Store below 30°C
* See Safety Data Sheet (SDS)
* For emergency medical information in USA, call ..........................
Inactive Ingredients:
Hydrogen Peroxide 0.125% v/v, Water (aqua), Glycerin, Carbomer 940, Aminomethyl Propanol, Dettol Frag.
Questions Or Comments?
* Call: +91 40 4221 2432 / 33
* Email: [email protected]
Other
World Health Organization Recommended Formulation
Manufactured by:
Sanmed Healthcare Pvt. Ltd.
Plot No: 56, TSIIC, Biotech Park Phase-III
Karakapatla - 502279. India.
Packaging
Xepirub (81357101 1)
* Please review the disclaimer below.
