CHLORASEPTIC MAX

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2025-01-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:21

Label at a glance#

ProductCHLORASEPTIC MAX
Active ingredientMENTHOL, BENZOCAINE
Label structure12 sections

Indications and uses

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

Dosage and administration

Adults and children 6 years and older : Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth. Children under 6 years of age:  Do not use .

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each lozenge)

Benzocaine 15 mg

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each lozenge)

Menthol 10 mg

Purpose

OTC - PURPOSE SECTION

Oral pain reliever 

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

∙ pale, gray, or blue colored skin (cyanosis)

∙ headache

∙ rapid heart rate

∙ shortness of breath

∙ dizziness or lightheadedness

∙ fatigue or lack of energy

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.

If a skin reaction occurs, stop use and seek medical help right away.

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 unless directed by a doctor.

Do not use

OTC - DO NOT USE SECTION

∙ for teething

∙ in 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 - ASK DOCTOR 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 care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years and older: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
  • Children under 6 years of age: Do not use.

Other Information

OTHER SAFETY INFORMATION

  • Store between 15○ - 30○C (59○ - 86○F)
  • Protect from moisture
  • Check expiration date before using

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn syrup, FD&C blue no. 1, FD&C red no. 40, glycerin, natural & artificial flavors, propylene glycol, soy lecithin, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-800-552-7932 Chloraseptic.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chloraseptic® Max
SORE THROAT
15 LOZENGES WILD BERRIES

     

Chloraseptic® Max SORE THROAT 15 LOZENGES WILD BERRIESChloraseptic® Max SORE THROAT 15 LOZENGES WILD BERRIES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046351benzocaine 15 MG / menthol 10 MG Oral LozengePSN3
1046353Chloraseptic Max Sore Throat 10 MG / 15 MG Oral LozengePSN3
1046353benzocaine 15 MG / menthol 10 MG Oral Lozenge [Chloraseptic Sore Throat]SBD3
1046351benzocaine 15 MG / menthol 10 MG Oral LozengeSCD3
1046353Chloraseptic Sore Throat Max (benzocaine 15 MG / menthol 10 MG) Oral LozengeSY3
1046353Chloraseptic Sore Throat Max Oral LozengeSY3

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
67172-114-61CHLORASEPTIC MAX1 in 1 CARTONLOZENGE13
67172-114-61CHLORASEPTIC MAX15 in 1 BLISTER PACKLOZENGE153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-114CHLORASEPTIC MAX (MENTHOL AND BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3Current NDC, Legacy NDC, 2 package rows20250122_edd12a2d-aa27-4f15-9ce6-862e4b6144c4.zip

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
67172-11467172-114-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
CHLORASEPTIC MAXMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.edd12a2d-aa27-4f15-9ce6-862e4b6144c42025-01-23WarningsExact identifier
ndc (package): 67172-114-61
ndc (product): 67172-114
ndc11 (package): 67172011461
spl id: 15bd3a83-c1ab-4f62-a7fd-4d98011b1eb5
spl set id: edd12a2d-aa27-4f15-9ce6-862e4b6144c4

Reported adverse events (FAERS/openFDA)#

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