Active Ingredient
Alcohol 70% v/v
Sunna Pure Hand Sanitizer Gel
FDA Label NDC 79147-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spa Dent Inc. for the product Sunna Pure Hand Sanitizer Gel (NDC 79147-003). 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, purpose, use(s), warnings, do not use, when using this product, stop use and ask a doctor, 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
Antiseptic
Use(S)
• Antiseptic (skin) cleanser • Medicated (skin) cleanser • Antibacterial (skin) cleanser • Effective in destroying (harmful) bacteria to provide antiseptic cleansing • For personal hand hygiene to help prevent the spread of bacteria
Warnings
• For external use only. Flammable. Keep away from heat or flame.
Do Not Use
• in children less than 2 months of age • on open skin wounds.
When Using This Product
• keep out of eyes, ears, and mouth • In case of contact with eyes, rinse eyes thoroughly with water.
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.
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.
Other Information
• Store between 15° - 30° C (59° - 86° F) out of direct sunlight • Avoid freezing and excessive heat above 40° C (104° F).
Do not use this product if tamper-resistant seal is broken when opened.
Inactive Ingredients
Purified Water, Aloe Barbadensis Leaf Juice, Vitamin E, Glycerin, Carbomer Copolymer, Aminomethyl Propanol
Package Labeling:
Label (Label)
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