Delist - EMS (as CMO) - Antiseptic Sinofresh Kool Blast (59228-105)

ANTISEPTIC SINOFRESH KOOL BLAST THROAT by

Drug Labeling and Warnings

ANTISEPTIC SINOFRESH KOOL BLAST THROAT by is a Homeopathic medication manufactured, distributed, or labeled by EMS Contract Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC SINOFRESH KOOL BLAST THROAT- mentha piperita spray 
EMS Contract Packaging

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Delist - EMS (as CMO) - Antiseptic Sinofresh Kool Blast (59228-105)

ACTIVE INGREDIENTS

MENTHA PIPERITA 3X

PURPOSE

ORAL ANTISEPTIC

USES

• KILLS GERMS AND BACTERIA
• REDUCES GERMS AND BACTERIA IN THE MOUTH AND THROAT

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 WITH WATER
• DO NOT SHARE DISPENSER WITH OTHERS

STOP USE AND ASK DOCTOR:

• IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR WORSENS
• A RASH OR IRRITATION OCCURS

KEEP OUT OF REACH OF CHILDREN.

IF MORE THAN IS USED FOR SPRAYING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY, 800-222-1222

DIRECTIONS

• ADULTS AND CHILDREN 12 YEARS AND OLDER, 3 TO 4 SPRAYS IN THE THROAT, THREE TIMES A DAY, OR AS NEEDED
• CHILDREN UNDER 12 YEARS ASK A DOCTOR

OTHER INFORMATION

STORE AT ROOM TEMPERATURE, AWAY FROM DIRECT SUNLIGHT

INACTIVE INGREDIENTS

AQUA (WATER), BENZALKONIUM CHLORIDE, CETYLPYRIDINIUM CHLORIDE, EDETATE DISODIUM, EUCALYPTUS OIL, GLYCERIN, MENTHOL, POLYSORBATE 80, SORBITOL, SUCRALOSE, XYLITOL

QUESTIONS?

888-460-4774

ANTISEPTIC SINOFRESH KOOL BLAST THROAT 
mentha piperita spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59228-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	3 [hp_X]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE SODIUM (UNII: MP1J8420LU)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59228-105-11	59.1 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/28/2020	12/22/2025

Labeler - EMS Contract Packaging (048602791)

Revised: 12/2025

Document Id: 46a1d671-1864-d030-e063-6294a90a115c

34390-5

Set id: 5a788a54-edf7-410a-8db4-ffa5cec7ab36

Version: 11

Effective Time: 20251223