CareOne Cold Sore Treatment

Manufacturer: American Sales Company | Ranir LLC
Effective date: 2011-11-14
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:35:43

Label at a glance#

ProductCareOne 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 contact1-877-242-3234

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 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1374851	benzalkonium chloride 0.13 % / camphor 3 % Topical Cream	PSN	2
1374851	benzalkonium chloride 1.3 MG/ML / camphor 30 MG/ML Topical Cream	SCD	2
1374851	benzalkonium chloride 0.13 % / camphor 3 % Topical Cream	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41520-407-01	2020-01-31	C162847	48780-1	9d75b9cf-e6d5-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-407-01	CareOne Cold Sore Treatment	1 in 1 PACKAGE	CREAM	1		2
41520-407-01	CareOne Cold Sore Treatment	2 g in 1 TUBE	CREAM	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-407	CAREONE COLD SORE TREATMENT (CAMPHOR) CREAM [AMERICAN SALES COMPANY]	2	Legacy NDC, 2 package rows	20130617_60a12af5-1dcd-45f6-b1ba-1ac68997e35b.zip

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 · 25 matching rows.

CareOne Cold Sore Treatment
Camphor
Benzalkonium Chloride
Benzalkonium
CAMPHOR (SYNTHETIC)
Alcohol
Aloe Vera Leaf
Arginine
Butylparaben
Ceresin
Cetearyl Isononanoate
Corymbia Citriodora Leaf Oil
Dipropylene Glycol Caprate/Caprylate Diester
Ethylparaben
Hexyldecanol
Hexyldecyl Laurate
Levomenthol
Methylparaben
PHENOXYETHANOL
Poloxamer 407
Propylparaben
Tea Tree Oil
Thymol
TOCOPHERYL NICOTINATE, D-.ALPHA.
Zinc Chloride

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41520-407	41520-407-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
Corymbia Citriodora Leaf Oil	M63U6N96EB	IACT
Dipropylene Glycol Caprate/Caprylate Diester	R6G12EY23X	IACT
Ethylparaben	14255EXE39	IACT
Hexyldecanol	151Z7P1317	IACT
Hexyldecyl Laurate	0V595C1P6M	IACT
Levomenthol	BZ1R15MTK7	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

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	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	LIQUID / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/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
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	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
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	TABLET, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Arginine	ARGININE	94ZLA3W45F	TABLET, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Poloxamer 407	POLOXAMER 407	TUF2IVW3M2	LOTION / TOPICAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Ethylparaben	ETHYLPARABEN	14255EXE39	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Poloxamer 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 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	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Levomenthol	LEVOMENTHOL	BZ1R15MTK7	TABLET / ORAL		5 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	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	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Zinc Chloride	ZINC CHLORIDE	86Q357L16B	SOLUTION / OPHTHALMIC	NA		Exact identifier — unii candidate 5 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
4d1ca466-b6db-4257-ae97-8d2e67ac5a88			60a12af5-1dcd-45f6-b1ba-1ac68997e35b	2011-11-14	Warnings	Exact identifier spl id: 4d1ca466-b6db-4257-ae97-8d2e67ac5a88 spl set id: 60a12af5-1dcd-45f6-b1ba-1ac68997e35b

Reported adverse events (FAERS/openFDA)#

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