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NDC 59228-0105-11 ANTISEPTIC SINOFRESH KOOL BLAST THROAT 3 [hp_X]/100mL Details

ANTISEPTIC SINOFRESH KOOL BLAST THROAT 3 [hp_X]/100mL

ANTISEPTIC SINOFRESH KOOL BLAST THROAT is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by EMS Contract Packaging. The primary component is MENTHA PIPERITA.

Product Information

NDC	59228-0105
Product ID	59228-105_dd46464c-1b3a-6b27-e053-2995a90a246f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ANTISEPTIC SINOFRESH KOOL BLAST THROAT
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHA PIPERITA
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	ORAL
Active Ingredient Strength	3
Active Ingredient Units	[hp_X]/100mL
Substance Name	MENTHA PIPERITA
Labeler Name	EMS Contract Packaging
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59228-0105-11 (59228010511)

Pricing Information	N/A
NDC Package Code	59228-105-11
Billing NDC	59228010511
Package	59.1 mL in 1 BOTTLE (59228-105-11)
Marketing Start Date	2020-09-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5a788a54-edf7-410a-8db4-ffa5cec7ab36 Details

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - EMS Contract Packaging (048602791)

Revised: 4/2022

Document Id: dd46464c-1b3a-6b27-e053-2995a90a246f

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

Version: 8

Effective Time: 20220422