FDA.reportPublic FDA data

Chloraseptic Warming Green Tea Lozenge - 67172-020

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2026-03-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:48:54

Label at a glance#

ProductChloraseptic Warming Green Tea
Active ingredientBENZOCAINE
Label structure9 sections

Indications and uses

Temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth.

Dosage and administration

Adults and children 6 years of age and over : Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth. Children under 6 years of age :  contraindicated.  

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each lozenge)

Benzocaine 15 mg

Purpose

OTC - PURPOSE SECTION

Oral anesthetic/Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth.

Warnings

WARNINGS SECTION

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics. 

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age.

When using this product:

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a dentist or 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
  • Children under 6 years of age: contraindicated.  

Other information

OTHER SAFETY INFORMATION

  • Store below 25ºC.
  • Protect from moisture. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn syrup, Epigallocatechin Gallate (ECGC), FD&C Blue #1, FD&C Yellow #5 (tartrazine), Flavor, Honey, Propylene Glycol, Soy Lecithin, Sucrose, Glycerin, Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chloraseptic© 
Benzocaine Oral Anesthetic | Analgesic lozenges
warming
Grean Tea with real honey
18 lozenges

PRINCIPAL DISPLAY PANEL Chloraseptic© Benzocaine Oral Anesthetic | Analgesic 18 lozenges warming Grean Tea with real honey 18 lozengesPRINCIPAL DISPLAY PANEL Chloraseptic© Benzocaine Oral Anesthetic | Analgesic 18 lozenges warming Grean Tea with real honey 18 lozenges

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199071benzocaine 15 MG Oral LozengePSN2
1245378Chloraseptic Warming Sore Throat 15 MG Oral LozengePSN2
1245378benzocaine 15 MG Oral Lozenge [Chloraseptic]SBD2
199071benzocaine 15 MG Oral LozengeSCD2
1245378Chloraseptic 15 MG Oral LozengeSY2
1245378Chloraseptic Warming Sore Throat 15 MG Oral LozengeSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-020-02Chloraseptic Warming Green Tea18 in 1 BOTTLELOZENGE182

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67172-02067172-020-02

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
BENZOCAINEU3RSY48JW5ACTIB
CORN SYRUP9G5L16BK6NIACT
EPIGALLOCATECHIN GALLATEBQM438CTELIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
HONEYY9H1V576FHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
47c82b90-ab3f-41a9-9cca-9db488dd944a9f83b124-fe25-4bbe-84d7-2145e9c313892026-03-06WarningsExact identifier
spl id: 47c82b90-ab3f-41a9-9cca-9db488dd944a
spl set id: 9f83b124-fe25-4bbe-84d7-2145e9c31389

Reported adverse events (FAERS/openFDA)#

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