IRXAMIGRA (camphor- synthetic, menthol, unspecified form, and capsaicin liniment

IRxAmigra by

Drug Labeling and Warnings

IRxAmigra by is a Otc medication manufactured, distributed, or labeled by ActivPower Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

IRXAMIGRA 
camphor (synthetic), menthol, unspecified form, and capsaicin liniment

Product 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)