Active Ingredient
Ethyl alcohol 70%
Haku Gardenia Hand Sanitizer
FDA Label NDC 78857-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Src Company Co., Ltd. for the product Haku Gardenia Hand Sanitizer (NDC 78857-080). 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, inactive ingredients, purpose, warnings, keep out of reach of children, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Polysorbate 80, Aloe barbadensis leaf extract, Fragrance
Purpose
ANTISEPTIC
Warnings
For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Uses
• Hand sanitizer to help reduce bacteria that potentially can cause disease.
• Recommended for repeated use.
Directions
• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.
• Not recommended for infants
Other Information
• Store between 1℃-30℃ (33.8℉-86℉)
• Avoid freezing and excessive heat above 40℃ (104℉)
* Please review the disclaimer below.
