Label: IRXAMIGRA (camphor- synthetic, menthol, unspecified form, and capsaicin liniment
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Contains inactivated NDC Code(s)
NDC Code(s): 72586-004-01 - Packager: ActivPower Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 2, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
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INGREDIENTS AND APPEARANCE
IRXAMIGRA
camphor (synthetic), menthol, unspecified form, and capsaicin linimentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72586-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 100 mg in 1 mL MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 50 mg in 1 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.75 mg in 1 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) CLOVE OIL (UNII: 578389D6D0) FRANKINCENSE OIL (UNII: 67ZYA5T02K) CINNAMON OIL (UNII: E5GY4I6YCZ) CURCUMIN (UNII: IT942ZTH98) BLACK PEPPER OIL (UNII: U17J84S19Z) PETROLATUM (UNII: 4T6H12BN9U) CASTOR OIL (UNII: D5340Y2I9G) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72586-004-01 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 07/01/2020 Labeler - ActivPower Inc. (116767431)
