FDA.reportPublic FDA data

NICE SORE THROAT Honey Lemon

Manufacturer
Leosons Overseas Corp
Effective date
2024-11-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:20

Label at a glance#

ProductNICE SORE THROAT Honey Lemon
Active ingredientPHENOL
Label structure10 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:

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

caramel color, citric acid, FD&C yellow #6, flavor, glycerin, polysorbate 80, propylene glycol, sodium citrate, sodium saccharin, triacetin, and water

QUESTIONS?

OTC - QUESTIONS SECTION

1-855-452-9500or 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

HONEY LEMON FLAVOR

6 FL OZ (177 mL)

Nice Throat Honey LemonNice Throat Honey Lemon

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69626-0077-62024-11-20C16284748780-10191ceaa-67e3-198a-e063-dbdaa90aec3eN'ICE Sore Throat Honey Lemon
69626-0077-62023-07-28C16284748780-10191ceaa-67e3-198a-e063-dbdaa90aec3eN'ICE Sore Throat Honey Lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0077-6NICE SORE THROAT Honey Lemon177 mL in 1 BOTTLE, SPRAYSPRAY1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0077NICE SORE THROAT HONEY LEMON (PHENOL) SPRAY [LEOSONS OVERSEAS CORP]3Current NDC, Legacy NDC, 1 package rows20241122_601aea98-e6ab-de6f-e053-2a91aa0a824a.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69626-007769626-0077-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYSORBATE 806OZP39ZG8HIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CARAMELT9D99G2B1RIACT
TRIACETINXHX3C3X673IACT
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 Honey LemonPHENOLLeosons Overseas Corp601aea98-e6ab-de6f-e053-2a91aa0a824a2024-11-15WarningsExact identifier
ndc (package): 69626-0077-6
ndc (product): 69626-0077
ndc11 (package): 69626007706
spl id: 26f72f16-6643-ba14-e063-6294a90a5b54
spl set id: 601aea98-e6ab-de6f-e053-2a91aa0a824a

Reported adverse events (FAERS/openFDA)#

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