Indications and uses
temporarily relieves pain and itching commonly associated with fever blisters and cold sores
temporarily relieves pain and itching commonly associated with fever blisters and cold sores
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
Camphor, 1.7%
Menthol, 0.7%
Phenol, 0.4%
External Analgesic
For external use only
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor
Alum, beeswax, cocoa butter, flavor, lanolin, petrolatum, salicylic acid
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-6080-02 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-32f1-60a7-e053-dbdaa90a05bd | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-6080-01 | Medicated Lip Balm | 4 g in 1 CONTAINER | STICK | 4 | 2 | |
| 0363-6080-02 | Medicated Lip Balm | 2 in 1 BLISTER PACK | STICK | 2 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CAMPHOR (NATURAL) | ACTIVE INGREDIENT | N20HL7Q941 | 2 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 2 | |
| PHENOL | ACTIVE INGREDIENT | 339NCG44TV | 2 | |
| CAMPHOR (NATURAL) | ACTIVE MOIETY | N20HL7Q941 | 2 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 2 | |
| PHENOL | ACTIVE MOIETY | 339NCG44TV | 2 | |
| ALUM, POTASSIUM | INACTIVE INGREDIENT | 1L24V9R23S | 2 | |
| COCOA BUTTER | INACTIVE INGREDIENT | 512OYT1CRR | 2 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 2 | |
| SALICYLIC ACID | INACTIVE INGREDIENT | O414PZ4LPZ | 2 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-6080 | 0363-6080-01, 0363-6080-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CAMPHOR (NATURAL) | N20HL7Q941 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
| PHENOL | 339NCG44TV | ACTIB |
| ALUM, POTASSIUM | 1L24V9R23S | IACT |
| WHITE WAX | 7G1J5DA97F | IACT |
| COCOA BUTTER | 512OYT1CRR | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / RECTAL | 105 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / OPHTHALMIC | 3 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM / TOPICAL | 500 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SPRAY / NASAL | NA | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SHAMPOO / TOPICAL | 2 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / TOPICAL | 10 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM, AUGMENTED / TOPICAL | 10 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / TOPICAL | 10 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| ALUM, POTASSIUM | POTASSIUM ALUM | 1L24V9R23S | POWDER / VAGINAL | 14 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / VAGINAL | 2 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | LOTION / TOPICAL | 1 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | EMULSION / TOPICAL | 0.25 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | OINTMENT, AUGMENTED / TOPICAL | 429 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | SUPPOSITORY / RECTAL | 265 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CAPSULE, EXTENDED RELEASE / ORAL | 71 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, COATED / ORAL | 3 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | OINTMENT / TOPICAL | 2100 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w | ||
| COCOA BUTTER | COCOA BUTTER | 512OYT1CRR | SUPPOSITORY / RECTAL | 2280 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET / ORAL | 5 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | AEROSOL, FOAM / TOPICAL | 2 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| ALUM, POTASSIUM | POTASSIUM ALUM | 1L24V9R23S | SUPPOSITORY / VAGINAL | 17.2 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM / VAGINAL | 40 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | LOTION / TOPICAL | 1.5 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CAPSULE / ORAL | 79 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, DELAYED RELEASE / ORAL | 0.08 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6a82dba6-f36e-448c-af67-e98bb33f6da8 | 0bb75602-7eb1-4d4a-9271-c7f84ff552f7 | 2013-11-15 | Warnings | 6a82dba6-f36e-448c-af67-e98bb33f6da8 0bb75602-7eb1-4d4a-9271-c7f84ff552f7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.