Medicated Lip Balm

Manufacturer
Walgreen Co | Lee Pharmaceuticals
Effective date
2013-11-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:37:27

Label at a glance#

ProductMedicated Lip Balm
Active ingredientCAMPHOR (NATURAL), MENTHOL, PHENOL
Label structure11 sections

Indications and uses

temporarily relieves pain and itching commonly associated with fever blisters and cold sores

Dosage and administration

adults and children 2 years of age and older, apply to lips not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor, 1.7%

Menthol, 0.7%

Phenol, 0.4%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves pain and itching commonly associated with fever blisters and cold sores

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product keep out of eyes.  Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor

  • if rash occurs
  • symptoms last for more than 7 days or clear up and occur agin within a few days

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 lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alum, beeswax, cocoa butter, flavor, lanolin, petrolatum, salicylic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CardCard

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-6080-022019-11-27C16284748780-19855e2a2-32f1-60a7-e053-dbdaa90a05bdDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6080-01Medicated Lip Balm4 g in 1 CONTAINERSTICK42
0363-6080-02Medicated Lip Balm2 in 1 BLISTER PACKSTICK22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6080MEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2Legacy NDC, 2 package rows20131115_0bb75602-7eb1-4d4a-9271-c7f84ff552f7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9412
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
PHENOLACTIVE INGREDIENT339NCG44TV2
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9412
MENTHOLACTIVE MOIETYL7T10EIP3A2
PHENOLACTIVE MOIETY339NCG44TV2
ALUM, POTASSIUMINACTIVE INGREDIENT1L24V9R23S2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR2
LANOLININACTIVE INGREDIENT7EV65EAW6H2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-60800363-6080-01, 0363-6080-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 1 · 45 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii candidate
15 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM, AUGMENTED / TOPICAL10 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
ALUM, POTASSIUMPOTASSIUM ALUM1L24V9R23SPOWDER / VAGINAL14 mgExact identifier — unii candidate
2 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
15 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FLOTION / TOPICAL1 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT, AUGMENTED / TOPICAL429 mgExact identifier — unii candidate
15 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FSUPPOSITORY / RECTAL265 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, COATED / ORAL3 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii candidate
15 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
COCOA BUTTERCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate
WHITE WAXWHITE WAX7G1J5DA97FTABLET / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
ALUM, POTASSIUMPOTASSIUM ALUM1L24V9R23SSUPPOSITORY / VAGINAL17.2 mgExact identifier — unii candidate
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / VAGINAL40 mgExact identifier — unii candidate
15 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE / ORAL79 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, DELAYED RELEASE / ORAL0.08 mgExact identifier — unii candidate
15 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 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
6a82dba6-f36e-448c-af67-e98bb33f6da80bb75602-7eb1-4d4a-9271-c7f84ff552f72013-11-15WarningsExact identifier
spl id: 6a82dba6-f36e-448c-af67-e98bb33f6da8
spl set id: 0bb75602-7eb1-4d4a-9271-c7f84ff552f7

Reported adverse events (FAERS/openFDA)#

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