Dosage and administration
Use only as directed Adults and children 12 years of age and older; apply to affected area not ore than 3 to 4 times daily Children under 12 years of age; ask a doctor
Doloran
- Manufacturer
- Hector Rivera Garzon y Compania. S. en C.
- Effective date
- 2019-12-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 23:02:25
Label at a glance#
ProductDoloran
Active ingredientMENTHOL, CAMPHOR, (-)-, METHYL SALICYLATE
Label structure8 sections
Label contents#
Full prescribing information#
Active Ingredients
Active Ingredients Purpose
Menthol _______________________________ 2.0% Topical Analgesic
Camphor ______________________________ 8.0% Topical Analgesic
Methyl Salicylate_________________________ 8.0% Topical Analgesic
Purpose
Topical Analgesic
Use
Temporarily relieves the minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only
- Do not use on wounds or damaged skin with a healing pad
- Do not use on a child under 12 years of age with arthritis-like conditions
Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of htis product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children to avoid accidental ingestion.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- Use only as directed
- Adults and children 12 years of age and older; apply to affected area not ore than 3 to 4 times daily
- Children under 12 years of age; ask a doctor
INACTIVE INGREDIENT SECTION
Inactive Ingredients (Petrolatum, anhydrous lanolin, parrafin)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71016-001-20 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1d9d-fd44-e053-dadaa90aa01b | 3dbdca24-10ee-3f5b-e054-00144ff88e88 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71016-001-20 | Doloran | 20 g in 1 BOX | OINTMENT | 20 | 5 | |
| 71016-001-20 | Doloran | 1 in 1 BOX | OINTMENT | 1 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Doloran
- Menthol, Camphor, Methyl Salicylate
- MENTHOL
- CAMPHOR, (-)-
- LANOLIN
- PARAFFIN
- PETROLATUM
- METHYL SALICYLATE
- SALICYLIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71016-001 | 71016-001-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| CAMPHOR, (-)- | 213N3S8275 | ACTIB |
| LANOLIN | 7EV65EAW6H | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 9ab28852-3e33-308b-e053-2a95a90ae192 | 3dbdca24-10ee-3f5b-e054-00144ff88e88 | 2019-12-27 | Warnings | 9ab28852-3e33-308b-e053-2a95a90ae192 3dbdca24-10ee-3f5b-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.