SINOFRESH KOOLBLAST- sinofresh koolblast oral spray spray 
ZapVir Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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SinoFresh KoolBlast Oral Antiseptic Spray

Active Ingredients

Mentha Piperita 3X

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

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

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
Stop use and ask doctor if:
• condition persists for more than 7 days or worsens
• a rash or irritation occurs

Principal Display Panel

SINOFRESH KOOLBLAST 
sinofresh koolblast oral spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79961-003
Route of AdministrationOROPHARYNGEAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MENTHOL (UNII: L7T10EIP3A)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79961-003-0160 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2020
Labeler - ZapVir Inc. (117600850)
Registrant - ZapVir Inc. (117600850)
Establishment
NameAddressID/FEIBusiness Operations
EMS Acquisition Corp048602791manufacture(79961-003)

Revised: 10/2020
Document Id: b17f470e-2eb1-b03a-e053-2995a90ad443
Set id: b17f470e-2eb0-b03a-e053-2995a90ad443
Version: 1
Effective Time: 20201012
 
ZapVir Inc.