FDA Label for Amino Active Topical Analgesic Cream

View Indications, Usage & Precautions

Amino Active Topical Analgesic Cream Product Label

The following document was submitted to the FDA by the labeler of this product Vireo Systems, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredients



Histamine DHCl 0.025%


Purpose



Topical Analgesic


Uses:



  • For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.
  • Provides penetrating pain relief.

Warnings:



For External Use Only


Do Not



  • apply to wounds or damaged skin.
  • bandage tightly.

When Using This Product



  • Avoid contact with eyes.

Stop Use And Ask A Doctor If



  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.



If swallowed, get medical help orcontact a Poison Control Center right away.


If Pregnant Or Breastfeeding



ask a health professional before use.


Directions:



  • Adults and children 2 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:



  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:



Alpha GEE®, Cetyl Alcohol, Colloidal Oatmeal, Dioctyl Sodium Sulfosuccinate, Glyceryl MonoStearate, Polyethylene Glycol, Polyethylene Glycol 400, Polyethylene Glycol 3350, Sodium Hydroxide.


Package Labeling:




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