Indications and uses
For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains
Ubredol - Pharmadel LLC
- Manufacturer
- Pharmadel LLC
- Effective date
- 2026-03-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:51:47
Label at a glance#
ProductUbredol
Active ingredientMETHYL SALICYLATE
Label structure8 sections
Dosage and administration
adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient & Purpose
OTC - PURPOSE SECTION
| Active ingredient | Purpose |
| Methyl salicylate 10% .................. | Topical analgesic |
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only. Avoid contact with the eyes.
Do not
- apply on wounds or irritated skin
- bandage tightly
Stop use and ask doctor immediately if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of children.
If swallowed get medical help, or contact a Poison Control Center immediately.
Directions
- adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: do not use, consult a doctor
Other information
- store between 59°- 86°F (15 - 30°C)
- do not use if clear seal over jar is broken, torn or missing
Inactive ingredients
camphor, D&C yellow #11, eucalyptus oil, lanolin oil, levomenthol, mineral oil, petrolatum, propylparaben, tea tree oil
Distributed by:
Pharmadel LLC
New Castle, DE 19720
+1-866-359-3478
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-377-03 | Ubredol | 85 g in 1 JAR | OINTMENT | 85 | 4 |
Products#
Every source-derived product name is available through these pages.
- Ubredol
- Methyl Salicylate
- CAMPHOR, (-)-
- LEVOMENTHOL
- D&C YELLOW NO. 11
- MINERAL OIL
- PARAFFIN
- PROPYLPARABEN
- PETROLATUM
- SALICYLIC ACID
- LANOLIN OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-377 | 55758-377-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CAMPHOR, (-)- | 213N3S8275 | IACT |
| LEVOMENTHOL | BZ1R15MTK7 | IACT |
| D&C YELLOW NO. 11 | 44F3HYL954 | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
| LANOLIN OIL | OVV5IIJ58F | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-12-04 | monthly-update | 2026-06-03 17:45:21 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ubredol | METHYL SALICYLATE | Pharmadel LLC | fe96eead-1722-c05d-e053-6394a90a850f | 2026-03-26 | Warnings | 55758-377-03 55758-377 55758037703 4df2578b-c742-91c0-e063-6294a90adbec fe96eead-1722-c05d-e053-6394a90a850f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.