Active Ingredients
Mentha Piperita 3X
Sinofresh Koolblast
FDA Label NDC 79961-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zapvir Inc. for the product Sinofresh Koolblast (NDC 79961-003). 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 ingredients, purpose, warnings, stop use, keep our of reach of children, dosage and administration, indications and usage, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Antiseptic
Uses
• Kills germs and bacteria
• Reduces germs and bacteria in the mouth and throat
Warnings
Warnings
Ask a doctor before use if you have:
• had any medical procedures for the mouth or throat
• raw, scratchy or irritated throat
When using this product:
• do not spray in eyes. If contact occurs, rinse eyes
with water
• do not share dispenser with others
Warnings
Ask a doctor before use if you have:
• had any medical procedures for the mouth or throat
• raw, scratchy or irritated throat
When using this product:
• do not spray in eyes. If contact occurs, rinse eyes
with water
• do not share dispenser with others
Stop use and ask doctor if:
• condition persists for more than 7 days or worsens
• a rash or irritation occurs
Stop Use
Stop use and ask doctor if:
• condition persists for more than 7 days or worsens
• a rash or irritation occurs
Keep Our Of Reach Of Children
Keep out of reach of children.
If more than used for spraying is accidentally swallowed,
get medical help or contact a Poison Control Center
right away, 800-222-1222
Dosage And Administration
Directions
• Adults and children 12 years of age and older, 3 to 4
sprays in the throat, three times a day, or as needed
• Children under 12 years ask a doctor
Indications And Usage
Oral Antiseptic
• Reduces germs and bacteria in the mouth and throat
Inactive Ingredients
Inactive Ingredients: Aqua (water), benzalkonium chloride, cetylpyridinium chloride, edetate disodium, eucalyptus oil, glycerin,
menthol, polysorbate 80, sorbitol, sucralose, xylitol
* Please review the disclaimer below.
