SINOFRESH KOOLBLAST- sinofresh koolblast oral spray spray

SinoFresh KoolBlast by

Drug Labeling and Warnings

SinoFresh KoolBlast by is a Homeopathic medication manufactured, distributed, or labeled by ZapVir Inc., EMS Acquisition Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SINOFRESH KOOLBLAST 
sinofresh koolblast oral spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79961-003
Route of Administration	OROPHARYNGEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79961-003-01	60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/12/2020

Labeler - ZapVir Inc. (117600850)

Registrant - ZapVir Inc. (117600850)

Establishment
Name	Address	ID/FEI	Business Operations
EMS Acquisition Corp		048602791	manufacture(79961-003)