Ubredol

Manufacturer
Pharmadel LLC
Effective date
2024-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:55:41

Label at a glance#

ProductUbredol Max
Active ingredientCAMPHOR (NATURAL), METHYL SALICYLATE, MENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

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

Label contents#

Full prescribing information#

Active ingredients & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Camphor 3%................................Topical analgesic
Menthol 3.5%...............................Topical analgesic
Methyl salicylate 10% ..................Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not

OTC - DO NOT USE SECTION

  • apply to wounds or damaged skin
  • bandage tightly

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

  • store between (59-86°F)15-30°C
  • don’t use if clear seal over can is broken, torn, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #11, eucalyptus oil, lanolin oil, mineral oil, paraffin, propylparaben, tea tree, white petrolatum

Dist by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Made in India

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ubredol Max PDPUbredol Max PDP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-449UBREDOL MAX (CAMPHOR, MENTHOL, METHYL SALICYLATE) OINTMENT [PHARMADEL LLC]1Unmatched20240901_20ea6396-a0a8-5762-e063-6394a90a636f.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-44955758-449-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
437f9919-e66c-8776-e063-6394a90a7a9f20ea6396-a0a8-5762-e063-6394a90a636f2025-11-13WarningsExact identifier
spl set id: 20ea6396-a0a8-5762-e063-6394a90a636f

Reported adverse events (FAERS/openFDA)#

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