CARMEX COLD SORE treatment External Analgesic

Manufacturer: Carma Laboratories, Inc.
Effective date: 2019-10-21
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:06:37

Label at a glance#

ProductCARMEX COLD SORE treatment External Analgesic

Active ingredientBENZOCAINE

Label structure7 sections

Indications and uses

For the temporary relief of symptoms of cold sores and fever blisters

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 under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 10%

Purpose

OTC - PURPOSE SECTION

External Analgesic / Anti-Itch

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of symptoms of cold sores and fever blisters

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
When using this product keep out of eyes. Rinse with water to remove.
Do not exceed recommended dosage.
Stop use and ask a doctor or dentist if
- cold sore symptoms do not improve in 7 days
- irritation, pain, or redness persists or worsens
- swelling, rash, or fever develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 under 2 years of age: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cyclomethicone, polyethylene glycol 600, dimethicone, silica, petrolatum, phenyl trimethicone, PEG/PPG-19/19 dimethicone, mica, peg 12 dimethicone, titanium dioxide, polyurethane-40, menthol, tin oxide

CARMEX COLD SORE treatment External Analgesic 2g (10210-0012-0)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10210-0012-0	2024-12-12	C162847	48780-1	ba0f9c33-33f0-a910-e053-dadaa90a0b85	CARMEX COLD SORE treatment External Analgesic
10210-0012-0	2021-01-29	C162847	48780-1	ba0f9c33-33f0-a910-e053-dadaa90a0b85	CARMEX COLD SORE treatment External Analgesic

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	1
PEG/PPG-19/19 DIMETHICONE	INACTIVE INGREDIENT	EHH90CO7TL	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	1
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STANNIC OXIDE	INACTIVE INGREDIENT	KM7N50LOS6	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

CARMEX COLD SORE treatment External Analgesic
BENZOCAINE
CYCLOMETHICONE
POLYETHYLENE GLYCOL 600
DIMETHICONE
SILICON DIOXIDE
PETROLATUM
PHENYL TRIMETHICONE
PEG/PPG-19/19 DIMETHICONE
MICA
TITANIUM DIOXIDE
MENTHOL
STANNIC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10210-0012	10210-0012-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CYCLOMETHICONE	NMQ347994Z	IACT
POLYETHYLENE GLYCOL 600	NL4J9F21N9	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
PETROLATUM	4T6H12BN9U	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
PEG/PPG-19/19 DIMETHICONE	EHH90CO7TL	IACT
MICA	V8A1AW0880	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MENTHOL	L7T10EIP3A	IACT
STANNIC OXIDE	KM7N50LOS6	IACT
BENZOCAINE	U3RSY48JW5	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 145 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 9 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	SOLUTION / TOPICAL	11.57 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE, LIQUID FILLED / ORAL		1584 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE / ORAL		1742 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	AEROSOL, FOAM / TOPICAL	5.26 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET / ORAL	6 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	CREAM / TOPICAL	13 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2911a2ce-21e0-50fc-e063-6294a90a8c55			6d91a6e1-02b6-45da-8ef2-b8a8aa23d31a	2024-12-12	Warnings	Exact identifier spl set id: 6d91a6e1-02b6-45da-8ef2-b8a8aa23d31a

Reported adverse events (FAERS/openFDA)#

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