TopCare Cold Sore Treatment

Manufacturer: Topco Associates LLC
Effective date: 2021-03-03
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 22:49:39

Label at a glance#

ProductTopCare Cold Sore Treatment

Active ingredientBENZALKONIUM CHLORIDE, CAMPHOR (SYNTHETIC)

Label structure10 sections

Indications and uses

• for treatment of cold sores/fever blisters on the face or lips • temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters • first aid to help protect against infection in minor cuts, scrapes, burns, and sores

Dosage and administration

• clean the affected area • apply a small amount of this product to the affected area 1 to 3 times daily • rub in gently • may be covered with a sterile bandage • wash hands before and after applying cream • do not share this product with anyone • children under 12 years of age : ask a doctor

Storage and handling

store at room temperature

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-423-0139

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Camphor 3.0%

Purpose

OTC - PURPOSE SECTION

Cold sore/fever blister treatment/first aid antiseptic

Uses

INDICATIONS & USAGE SECTION

for treatment of cold sores/fever blisters on the face or lips
temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters
first aid to help protect against infection in minor cuts, scrapes, burns, and sores

Warnings

WARNINGS SECTION

For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.
Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
When using this product avoid contact with eyes. Use only as directed.
Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

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 at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

clean the affected area
apply a small amount of this product to the affected area 1 to 3 times daily
rub in gently
may be covered with a sterile bandage
wash hands before and after applying cream
do not share this product with anyone
children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, aloe barbadensis leaf juice, arginine, butylparaben, cetearyl isononanoate, dipropylene glycol dicaprylate/dicaprate, ethylparaben, eucalyptus globulus leaf oil, hexyl decyl laurate, hexyldecanole, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylparaben, thymol, tocopheryl nicotinate (vitamin e), zinc chloride

Questions or Comments?

OTC - QUESTIONS SECTION

Call us toll-free at 1-888-423-0139

Serious side effects associated with use of this product may be reported to this number.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1374851	Benzalkonium/Camphor (Topical)	benzalkonium chloride 1.3 MG/ML / camphor 30 MG/ML Topical Cream	SCD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-407-01	2021-03-03	C162847	48780-1	ba0f9c33-34a4-a910-e053-dadaa90a0b85	BPC 407 - Topco
36800-407-01	2021-01-29	C162847	48780-1	ba0f9c33-34a4-a910-e053-dadaa90a0b85	BPC 407 - Topco

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzalkonium Chloride	ACTIVE INGREDIENT	F5UM2KM3W7	2
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	2
Benzalkonium	ACTIVE MOIETY	7N6JUD5X6Y	2
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	2
Alcohol	INACTIVE INGREDIENT	3K9958V90M	2
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	2
Arginine	INACTIVE INGREDIENT	94ZLA3W45F	2
Butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	2
Ceresin	INACTIVE INGREDIENT	Q1LS2UJO3A	2
Cetearyl Isononanoate	INACTIVE INGREDIENT	P5O01U99NI	2
Corymbia Citriodora Leaf Oil	INACTIVE INGREDIENT	M63U6N96EB	2
Dipropylene Glycol Caprate/Caprylate Diester	INACTIVE INGREDIENT	R6G12EY23X	2
Ethylparaben	INACTIVE INGREDIENT	14255EXE39	2
Hexyldecanol	INACTIVE INGREDIENT	151Z7P1317	2
Hexyldecyl Laurate	INACTIVE INGREDIENT	0V595C1P6M	2
Levomenthol	INACTIVE INGREDIENT	BZ1R15MTK7	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
Poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	2
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	2
Tea Tree Oil	INACTIVE INGREDIENT	VIF565UC2G	2
Thymol	INACTIVE INGREDIENT	3J50XA376E	2
TOCOPHERYL NICOTINATE, D-.ALPHA.	INACTIVE INGREDIENT	WI1J5UCY5C	2
Zinc Chloride	INACTIVE INGREDIENT	86Q357L16B	2

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

TopCare Cold Sore Treatment
Camphor
BENZALKONIUM CHLORIDE
BENZALKONIUM
CAMPHOR (SYNTHETIC)
ALCOHOL
ALOE VERA LEAF
ARGININE
BUTYLPARABEN
CERESIN
CETEARYL ISONONANOATE
EUCALYPTOL
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE
ETHYLPARABEN
HEXYLDECANOL
CETYL LAURATE
MENTHOL, UNSPECIFIED FORM
METHYLPARABEN
PHENOXYETHANOL
POLOXAMER 407
PROPYLPARABEN
TEA TREE OIL
THYMOL
TOCOPHERYL NICOTINATE, D-.ALPHA.
ZINC CHLORIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-407	36800-407-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
CAMPHOR (SYNTHETIC)	5TJD82A1ET	ACTIB
ALCOHOL	3K9958V90M	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
ARGININE	94ZLA3W45F	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
CERESIN	Q1LS2UJO3A	IACT
CETEARYL ISONONANOATE	P5O01U99NI	IACT
EUCALYPTOL	RV6J6604TK	IACT
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE	O4446S9CRA	IACT
ETHYLPARABEN	14255EXE39	IACT
HEXYLDECANOL	151Z7P1317	IACT
CETYL LAURATE	I19DN3Q5ZP	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
TEA TREE OIL	VIF565UC2G	IACT
THYMOL	3J50XA376E	IACT
TOCOPHERYL NICOTINATE, D-.ALPHA.	WI1J5UCY5C	IACT
ZINC CHLORIDE	86Q357L16B	IACT
WATER	059QF0KO0R	IACT

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 5 · 276 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Arginine	ARGININE	94ZLA3W45F	POWDER, FOR SOLUTION / INTRAVENOUS	7.07 %w/v		Exact identifier — unii candidate 11 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Ethylparaben	ETHYLPARABEN	14255EXE39	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / ORAL		6 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Levomenthol	LEVOMENTHOL	BZ1R15MTK7	GUM, CHEWING / BUCCAL		113 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	OINTMENT / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	LIQUID / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Arginine	ARGININE	94ZLA3W45F	TABLET, FILM COATED / ORAL		25 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Poloxamer 407	POLOXAMER 407	TUF2IVW3M2	TABLET / ORAL		495 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Levomenthol	LEVOMENTHOL	BZ1R15MTK7	LOTION / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
Arginine	ARGININE	94ZLA3W45F	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 11 equally ranked IID candidates
Arginine	ARGININE	94ZLA3W45F	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		3600 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	TABLET, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Ceresin	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Poloxamer 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Levomenthol	LEVOMENTHOL	BZ1R15MTK7	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 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
5bc0faa6-bf49-4eaf-b00d-2da6df220eff			53ae8634-b9f9-436a-8d09-75a5c11fa894	2021-03-03	Warnings	Exact identifier spl id: 5bc0faa6-bf49-4eaf-b00d-2da6df220eff spl set id: 53ae8634-b9f9-436a-8d09-75a5c11fa894

Reported adverse events (FAERS/openFDA)#

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