Purple Mountain Clean Hand Sanitizer
FDA Label NDC 80120-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Edison Nation, Inc. for the product Purple Mountain Clean Hand Sanitizer (NDC 80120-101). 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 info:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients:
Isopropyl Alcohol 60% v/v
Ethyl Alcohol 10% v/v
Purpose:
antiseptic
Uses:
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are unavailable.
Warnings:
For external use only. Flammable. Keep away from heat and flame, avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Stop use and askdoctor if irritation or redness develops, or if 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.
Directions :
Place enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use with adult supervision. Not recommended for infants.
Other Info:
Store between 15-30C (59-86F).
Avoid freezing and excessive heat above 40C (104F).
Inactive Ingredients:
Carbomer, ethanolamine, polyethylene glycol, water USP, Fragrance.
Packaging
Purple2 (80120101 3)
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