Active Ingredient(S)
Ethyl alcohol 70% v/v
Instant Hand Sanitizer
FDA Label NDC 78026-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yangzhou Olande Cosmetic Co., Ltd. for the product Instant Hand Sanitizer (NDC 78026-015). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
antimicrobial
Use
Hand sanitizer to help reduce bacteria that potentially can cause disease. For
use when soap and water are not available.
Recommended for repeated use.
Warnings
For external use only.
Flammable keep away from heat, fire or flame.
Do Not Use
Do not use children less than 2 months of age on open skin wounds.
Otc - When Using
When using this product keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water and seek medical attention immediately.
Otc - Stop Use
Stop use or consult a doctor If irritation or rash occurs.
These may be signs of a serious condition.
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.
Use as needed no need to rinse with water.
For children under 6 years of age, use only under adult supervision.
Not recommender for infants.
Other Information
Store between 15-30°C(59-86°F)
Avoid freezing and excessive heat above 40°C(104°F)
Inactive Ingredients
Water, carbomer, triethanolamine
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