CARMEX COLD SORE treatment External Analgesic Skin Protectant

Manufacturer
Carma Laboratories, Inc.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:23:20

Label at a glance#

ProductCARMEX 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

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 10.0%

White Petrolatum 45.9%

Purpose

OTC - PURPOSE SECTION

External Analgesic / Anti-Itch

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" anesthetics

Stop use and ask a doctor 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

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 ageShould 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 sun
  • Store between 0°C to 28°C (32°F to 82.4°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

polyethylene glycol, HDI/trimethylol hexyllactone crosspolymer, mica, behenyl olivate, PPG-51 SMDI copolymer, titanium dioxide, synthetic wax, calcium silicate, silica, flavor, iron oxides (C.I. 77491), isopropyl titanium triisostearate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottlePackPack

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10210-002710210-0027-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
29119fd8-49f3-114e-e063-6294a90af6d4bada4108-4b3f-8ee6-e053-2995a90a90272024-12-12WarningsExact identifier
spl set id: bada4108-4b3f-8ee6-e053-2995a90a9027

Reported adverse events (FAERS/openFDA)#

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