Indications and uses
For temporary relief of minor aches and pains of muscles and joints associated with back aches arthritis strains sprains
Milagroso - Pharmadel LLC
- Manufacturer
- Pharmadel LLC
- Effective date
- 2026-03-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:51:37
Label at a glance#
ProductMilagroso
Active ingredientCAMPHOR (SYNTHETIC)
Label structure9 sections
Dosage and administration
adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor
Contacts and useful links#
Websitewww.pharmadel.com
www.pharmadel.com
www.pharmadel.comLabel contents#
Full prescribing information#
Active ingredient & Purpose
OTC - PURPOSE SECTION
| Active ingredient | Purpose |
Camphor 10 %............................................................. | Topical analgesic |
Uses
For temporary relief of minor aches and pains of muscles and joints associated with
- back aches
- arthritis
- strains
- sprains
Warnings
FOR EXTERNAL USE ONLY. Avoid contact with the eyes .
Do not
- apply to on wounds or damaged skin
- bandage tightly
Stop use and ask a doctor if
- condition worsens or 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 professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: consult a doctor
Other information
- store in a cool dry place
- do not use if seal over cap is broken, torn, or missing
Inactive Ingredients
cyclomethicone 5, petrolatum
Questions or Comments?
1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Dist. by:
Pharmadel LLC
Georgetown, DE 19720
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-417-02 | Milagroso | 57 g in 1 JAR | OINTMENT | 57 | 5 |
Products#
Every source-derived product name is available through these pages.
- Milagroso
- Camphor
- PETROLATUM
- CAMPHOR (SYNTHETIC)
- CYCLOMETHICONE 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-417 | 55758-417-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PETROLATUM | 4T6H12BN9U | IACT |
| CAMPHOR (SYNTHETIC) | 5TJD82A1ET | ACTIB |
| CYCLOMETHICONE 5 | 0THT5PCI0R | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2025-12-04 | monthly-update | 2026-06-03 17:45:25 |
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 |
|---|---|---|---|---|---|---|
| Milagroso | CAMPHOR | Pharmadel LLC | 12b0401c-84d5-07cd-e063-6394a90a052c | 2026-03-26 | Warnings | 55758-417-02 55758-417 55758041702 4df21676-902c-2e91-e063-6394a90afffb 12b0401c-84d5-07cd-e063-6394a90a052c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.