FDA.reportPublic FDA data

Burts Bees Rapid Rescue Cold Sore Treatment

Manufacturer
Burts Bees
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:40:23

Label at a glance#

ProductBurts Bees Rapid Rescue Cold Sore Treatment
Active ingredientCAMPHOR (NATURAL), GLYCERIN
Label structure10 sections

Indications and uses

Temporarily relieves pain and itching associated with fever blisters and cold sores.  Relieves dryness and softens cold sores and fever blisters

Dosage and administration

Wash hands before and after applying squeeze tube to dispense and gently smooth onto affected area. Adults  & children 2 years of age and older: Apply to affected area up to 4 times daily. Children between 2-12 years of age:Apply under adult supervision Children under 2 years of age: Do not use.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.25%......... fever blister/cold sore treatment

Glycerin 22.25%......... fever blister/cold sore treatment

OTC - PURPOSE SECTION

fever blister/cold sore treatment

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching associated with fever blisters and cold sores.  Relieves dryness and softens cold sores and fever blisters

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes.

Stop Use and ask a doctor

OTC - STOP USE SECTION

if condition worses, symptoms last more than 7 days, or condition clears up and occurs again within a few days.

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

  • Wash hands before and after applying

squeeze tube to dispense and gently smooth onto affected area.

  • Adults  & children 2 years of age and older: Apply to affected area up to 4 times daily.
  • Children between 2-12 years of age:Apply under adult supervision
  • Children under 2 years of age: Do not use.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol, behenyl alcohol, glyceryl laurate, jojoba seed oil, lanolin, meadowfoam seed oil, menthol, pepperming oil, rhubarb root extract, sage leaf extract, sodium phytate, sucrose distearate, sucrose stearate, tocopherol, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTubeRRfrontRRfrontRRbackRRback

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2699129camphor 0.25 % / glycerin 22.25 % Topical OintmentPSN11
2699129camphor 0.0025 MG/MG / glycerin 0.223 MG/MG Topical OintmentSCD11
2699129camphor 0.25 % / glycerin 22.25 % Topical OintmentSY11
2699129camphor 0.25 % / glycerin 22.3 % Topical OintmentSY11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
26052-489-00Burts Bees Rapid Rescue Cold Sore Treatment1.98 g in 1 TUBEOINTMENT1.9811
26052-489-01Burts Bees Rapid Rescue Cold Sore Treatment1 in 1 BLISTER PACKOINTMENT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
26052-489BURTS BEES RAPID RESCUE COLD SORE TREATMENT (CAMPHOR, GLYCERIN) OINTMENT [BURTS BEES]11Current NDC, 2 package rows20241206_9f89735d-205f-4d3e-a1e1-ecc96284fe98.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
26052-48926052-489-00, 26052-489-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCOSANOL9G1OE216XYIACT
WATER059QF0KO0RIACT
LANOLIN7EV65EAW6HIACT
SUCROSE DISTEARATE33X4X4B90SIACT
SUCROSE STEARATE274KW0O50MIACT
GLYCERYL LAURATEY98611C087IACT
MENTHA PIPERITA79M2M2UDA9IACT
ALCOHOL3K9958V90MIACT
MENTHOLL7T10EIP3AIACT
RHEUM PALMATUM ROOTG025DAL7CEIACT
SAGE065C5D077JIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
PHYTATE SODIUM88496G1ERLIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
GLYCERINPDC6A3C0OXACTIB

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
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
ndc (package): 26052-489-01
ndc (package): 26052-489-00
ndc (product): 26052-489
ndc11 (package): 26052048901
ndc11 (package): 26052048900
spl id: 28635f65-790c-5abb-e063-6394a90aa07f
spl set id: 9f89735d-205f-4d3e-a1e1-ecc96284fe98

Reported adverse events (FAERS/openFDA)#

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