Premier Value Cold Sore Treatment

Manufacturer
Premier Value | Ranir LLC
Effective date
2013-04-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:35:43

Label at a glance#

ProductPremier Value 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

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

Premier Value Cold Sore Treatment
Premier Value Cold Sore Treatment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1374851benzalkonium chloride 0.13 % / camphor 3 % Topical CreamPSN2
1374851benzalkonium chloride 1.3 MG/ML / camphor 30 MG/ML Topical CreamSCD2
1374851benzalkonium chloride 0.13 % / camphor 3 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-407-012020-01-31C16284748780-19d75b9d0-c211-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-407-01Premier Value Cold Sore Treatment1 in 1 PACKAGECREAM12
68016-407-01Premier Value Cold Sore Treatment2 g in 1 TUBECREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-407PREMIER VALUE COLD SORE TREATMENT (CAMPHOR) CREAM [PREMIER VALUE]2Legacy NDC, 2 package rows20130617_549146c3-b519-43e2-87fc-d2dc024133b7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W72
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET2
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET2
AlcoholINACTIVE INGREDIENT3K9958V90M2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X2
ArginineINACTIVE INGREDIENT94ZLA3W45F2
ButylparabenINACTIVE INGREDIENT3QPI1U3FV82
CeresinINACTIVE INGREDIENTQ1LS2UJO3A2
Cetearyl IsononanoateINACTIVE INGREDIENTP5O01U99NI2
Corymbia Citriodora Leaf OilINACTIVE INGREDIENTM63U6N96EB2
Dipropylene Glycol Caprate/Caprylate DiesterINACTIVE INGREDIENTR6G12EY23X2
EthylparabenINACTIVE INGREDIENT14255EXE392
HexyldecanolINACTIVE INGREDIENT151Z7P13172
Hexyldecyl LaurateINACTIVE INGREDIENT0V595C1P6M2
LevomentholINACTIVE INGREDIENTBZ1R15MTK72
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M22
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH2
Tea Tree OilINACTIVE INGREDIENTVIF565UC2G2
ThymolINACTIVE INGREDIENT3J50XA376E2
TOCOPHERYL NICOTINATE, D-.ALPHA.INACTIVE INGREDIENTWI1J5UCY5C2
Zinc ChlorideINACTIVE INGREDIENT86Q357L16B2

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-40768016-407-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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 ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Zinc ChlorideZINC CHLORIDE86Q357L16BTABLET / ORAL14 mgExact identifier — unii candidate
5 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2TABLET / ORAL495 mgExact identifier — unii candidate
15 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHDROPS / NASAL14 mgExact identifier — unii candidate
68 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
ArginineARGININE94ZLA3W45FTABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
11 equally ranked IID candidates
ThymolTHYMOL3J50XA376EPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii candidate
68 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2CAPSULE / ORAL468 mgExact identifier — unii candidate
15 equally ranked IID candidates
LevomentholLEVOMENTHOLBZ1R15MTK7LOTION / TOPICAL0.08 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2CAPSULE, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
15 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAVENOUS5 mgExact identifier — unii candidate
68 equally ranked IID candidates
LevomentholLEVOMENTHOLBZ1R15MTK7SOLUTION / TOPICAL0.08 %w/vExact identifier — unii candidate
10 equally ranked IID candidates
ThymolTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
CeresinCERESINQ1LS2UJO3ACREAM / VAGINAL280 mgExact identifier — unii candidate
2 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2CREAM / TOPICAL13 mgExact identifier — unii candidate
15 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2GEL / PERIODONTAL155 mgExact identifier — unii candidate
15 equally ranked IID candidates
ArginineARGININE94ZLA3W45FTABLET, FILM COATED / ORAL25 mgExact identifier — unii candidate
11 equally ranked IID candidates
LevomentholLEVOMENTHOLBZ1R15MTK7TABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
10 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
48e07ed1-6cfa-41cf-90a4-f5d949874067549146c3-b519-43e2-87fc-d2dc024133b72013-04-16WarningsExact identifier
spl id: 48e07ed1-6cfa-41cf-90a4-f5d949874067
spl set id: 549146c3-b519-43e2-87fc-d2dc024133b7

Reported adverse events (FAERS/openFDA)#

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