Indications and uses
For application on to intact unbroken skin to help achieve the temporary relief of minor head and neck aches
IRxAmigra
- Manufacturer
- ActivPower Inc.
- Effective date
- 2020-07-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:19:53
Label at a glance#
ProductIRxAmigra
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure9 sections
Dosage and administration
For Topical use. Apply 2ml-3ml into forehead, temples or neck and rub in gently until it vanishes. May apply up to twice daily. Do not exceed recommended frequency of application. Do not apply heat after application. This product will produce a soothing relief and sensation of heat and warmth in the area of application.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredient | Purpose |
|---|---|
| Camphor 10% | Topical analgesic |
| Menthol 5% | Topical analgesic |
| Capsaicin 0.075% | Topical analgesic |
Uses
For application on to intact unbroken skin to help achieve the temporary relief of minor head and neck aches
Warnings
For external use only.
When using this product
Avoid contact with eyes and mucous membranes, wounds, damaged or irritated skin. Do not bandage or cover with wrap or apply any heat or heating pad to area after use. Wash hands with soap and water after using this product.
Stop use and Ask doctor if
Condition worsens. Severe skin irritation occurs. Pain persists for more than 4 days. Pain clears up and then recurs after a few days.
If pregnant or breast-feeding
This product has not been tested in pregnant or breast-feeding women. Consult the advice of your doctor before using this product in these situations.
Keep out of reach of children
Not recommended for use in children 12 years old or younger. If swallowed, get medical help or contact Poison Control immediately. If exposure to eyes, then wash copiously with cold water and consult a doctor. Components are not certified to be free of nut allergens. Do not use if allergic to nuts or peanuts or if allergic to any of the components without testing. Use on a small area for the first time. If rash or itching develops then discontinue use. If symptoms persist then consult a medical professional. If the intended area of application or joint is hot, red, bruised or swollen then do not apply this liniment and immediately seek professional medical help.
Inactive Ingredients
Eucalyptus Oil; Clove Oil; Frankincense Oil; Oleoresins of Cinnamon and Black Pepper; Curcumin; Ethanol; Castor Oil; Petrolatum; Sorbitan stearate.
Directions for Use
For Topical use. Apply 2ml-3ml into forehead, temples or neck and rub in gently until it vanishes. May apply up to twice daily. Do not exceed recommended frequency of application. Do not apply heat after application. This product will produce a soothing relief and sensation of heat and warmth in the area of application.
Questions/Comments
703-404-5905
SPL UNCLASSIFIED SECTION
Manufactured for/by ActivPower Inc.,Delaware, U.S.A under
license from ActivPower Inc. 13505 Dulles Technology Drive,
Suite 1A, Herndon, VA 20171, USA
PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
IRx Amigra
Topical Head and Neck Muscle Pain Relief
Doctor created. Clinic proven
Time tested Herbal Relief
Net Quantity: 50ml
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72586-004-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5bfa-a426-e053-dadaa90af4c2 | IRxAmigra |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72586-004-01 | IRxAmigra | 50 mL in 1 BOTTLE, PLASTIC | LINIMENT | 50 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- IRxAmigra
- CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, and CAPSAICIN
- CAMPHOR (SYNTHETIC)
- MENTHOL, UNSPECIFIED FORM
- CAPSAICIN
- EUCALYPTUS OIL
- CLOVE OIL
- FRANKINCENSE OIL
- CINNAMON OIL
- CURCUMIN
- BLACK PEPPER OIL
- PETROLATUM
- CASTOR OIL
- SORBITAN MONOSTEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72586-004 | 72586-004-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CAMPHOR (SYNTHETIC) | 5TJD82A1ET | ACTIB |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| CAPSAICIN | S07O44R1ZM | ACTIB |
| EUCALYPTUS OIL | 2R04ONI662 | IACT |
| CLOVE OIL | 578389D6D0 | IACT |
| FRANKINCENSE OIL | 67ZYA5T02K | IACT |
| CINNAMON OIL | E5GY4I6YCZ | IACT |
| CURCUMIN | IT942ZTH98 | IACT |
| BLACK PEPPER OIL | U17J84S19Z | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| CASTOR OIL | D5340Y2I9G | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
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 |
|---|---|---|---|---|---|---|
| 8577df63-b1dc-4add-b931-2c1eeb4caa7f | 216759f6-d5c5-4b53-bf6d-e9bc1881c5f4 | 2020-07-02 | Warnings | 8577df63-b1dc-4add-b931-2c1eeb4caa7f 216759f6-d5c5-4b53-bf6d-e9bc1881c5f4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.