BENZOCAINE, WHITE PETROLATUM

Manufacturer
Carma Laboratories, Inc.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:51

Label at a glance#

ProductCARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant
Active ingredientBENZOCAINE, WHITE PETROLATUM
Label structure7 sections

Indications and uses

• For temporary relief of pain and itching associated with symptoms of fever blisters and cold sores • Helps prevent and protect dry, chapped lips

Dosage and administration

Using clean, dry hands apply 1 to 2 small dollops of Carmex Cold Sore product to the tip of the finger and gently apply and spread evenly to the surface of the cold sore to ensure even coverage over areas of redness. Wash hands thoroughly after application.  Adults and children 2 years of age and older  Apply to affected area (lips) not more than 3 to 4 times daily  Children 2-12 years of age  Should be supervised...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 10%

White Petrolatum 44.69%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

• For temporary relief of pain and itching associated with symptoms of fever blisters and cold sores • Helps prevent and protect dry, chapped lips

Warnings

WARNINGS SECTION

For external use only

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” anesthetic

Stop use and ask a doctor or dentist if

OTC - STOP USE SECTION

• cold sore symptoms do not improve in 7 days

• irritation, pain, or redness persists or worsens • swelling, rash, or fever develops

Do not use on

OTC - DO NOT USE SECTION

• deep or puncture wounds • animal bites • serious burns

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove. Do not exceed recommended dosage.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Using clean, dry hands apply 1 to 2 small dollops of Carmex Cold Sore product to the tip of the finger and gently apply and spread evenly to the surface of the cold sore to ensure even coverage over areas of redness. Wash hands thoroughly after application.

 Adults and children 2 years of age and older Apply to affected area (lips) not more than 3 to 4 times daily
 Children 2-12 years of age Should be supervised in use of this product
 Children under 2 years of age Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

• Protect this product from excessive heat and direct sunlight • Store between 0° C to 28° C (32° F to 82.4° F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Polyethylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Titanium Dioxide, Behenyl Olivate, PPG-51 SMDI Copolymer, Mica, Synthetic Wax, Calcium Silicate, Flavor, Isopropyl Titanium Triisostearate, Silica, Tin Oxide, Iron Oxides (C.I 77491, C.I 77492, C.I. 77499)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2479726benzocaine 10 % / petrolatum 44.7 % Topical CreamPSN2
2479726benzocaine 100 MG/ML / petrolatum 447 MG/ML Topical CreamSCD2
2479726benzocaine 10 % / petrolatum 44.7 % Topical CreamSY2

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
10210-0048-1CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant1 in 1 BLISTER PACKCREAM12
10210-0048-1CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant2 g in 1 TUBECREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0048CARMEX MULTI-SYMPTOM 3 IN 1 COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT (BENZOCAINE, WHITE PETROLATUM) CREAM [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC, 2 package rows20231026_bbf0abcd-b7d6-b5e4-e053-2995a90a5240.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10210-004810210-0048-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin ProtectantBENZOCAINE, WHITE PETROLATUMCarma Laboratories, Inc.bbf0abcd-b7d6-b5e4-e053-2995a90a52402023-10-25WarningsExact identifier
ndc (package): 10210-0048-1
ndc (product): 10210-0048
ndc11 (package): 10210004801
spl id: 08883637-b8d6-23dc-e063-6394a90ae9f7
spl set id: bbf0abcd-b7d6-b5e4-e053-2995a90a5240

Reported adverse events (FAERS/openFDA)#

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