FDA.reportPublic FDA data

NICE SORE THROAT Spearmint

Manufacturer
Leosons Overseas Corp
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:20

Label at a glance#

ProductNICE SORE THROAT Spearmint
Active ingredientPHENOL
Label structure9 sections

Indications and uses

For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Dosage and administration

apply to the affected area allow to remain in place for at least 15 seconds, then spit out use every 2 hours or as directed by a doctor or dentist age dose adults and children 12 years of age and older for each application, spray 5 times children 3 to under 12 years should be supervised in use of this product for each application, spray 3 times children under 3 years of age consult a doctor or dentist

Label contents#

Full prescribing information#

Active Ingredient & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurposes
Phenol 1.4%Oral Anesthetic/ Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Warnings

WARNINGS SECTION

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops
  • difficulty in breathing occurs

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and all drugs out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply to the affected area
  • allow to remain in place for at least 15 seconds, then spit out
  • use every 2 hours or as directed by a doctor or dentist
agedose
adults and children 12 years of age and olderfor each application, spray 5 times
children 3 to under 12 years

should be supervised in use of this product

for each application, spray 3 times

children under 3 years of ageconsult a doctor or dentist

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C green #5, D&C yellow #10, FD&C green #3, flavor, glycerin, propylene glycol, sodium saccharin, and water.

Questions?

OTC - QUESTIONS SECTION

1-855-452-9500 or email at info@leosonsintl.com

Distributed by:

SPL UNCLASSIFIED SECTION

LEOSONS
Albany, New York 12205

Made in USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUGAR FREE • ALCOHOL FREE • ASPIRIN FREE

N'ICE®

P H E N O L / O R A L A N E S T H E T I C

Sore Throat Spray

Fast acting, long lasting relief of minor sore throat and mouth pain

SPEARMINT FLAVOR

6 FL OZ (177 mL)

NICE Throat SpearmintNICE Throat Spearmint

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69626-0048-62024-11-20C16284748780-10191ceaa-6d97-198a-e063-dbdaa90aec3eNICE Sore Throat Spearmint
69626-0048-62023-07-28C16284748780-10191ceaa-6d97-198a-e063-dbdaa90aec3eNICE Sore Throat Spearmint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0048-6NICE SORE THROAT Spearmint177 mL in 1 BOTTLE, SPRAYSPRAY1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0048NICE SORE THROAT SPEARMINT (PHENOL) SPRAY [LEOSONS OVERSEAS CORP]4Current NDC, Legacy NDC, 1 package rows20241122_5fc68f04-ec15-11c0-e053-2a91aa0a1952.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69626-004869626-0048-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
D&C GREEN NO. 58J6RDU8L9XIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
PHENOL339NCG44TVACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICE SORE THROAT SpearmintPHENOLLeosons Overseas Corp5fc68f04-ec15-11c0-e053-2a91aa0a19522024-11-20WarningsExact identifier
ndc (package): 69626-0048-6
ndc (product): 69626-0048
ndc11 (package): 69626004806
spl id: 275a09a6-a989-6f3c-e063-6394a90ab0a6
spl set id: 5fc68f04-ec15-11c0-e053-2a91aa0a1952

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.