Amino Activ Pain Relief Cream
FDA Label NDC 82908-027

15 label sections · Submitted to the FDA by Vireo Systems, Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vireo Systems, Inc for the product Amino Activ Pain Relief (NDC 82908-027). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses:, warnings, do not use:, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Histamine Dihydrochloride 0.025%

Purpose

Topical Analgesic

Uses:

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

Warnings

For External Use Only

Do Not Use:

  • on wounds or damaged skin or if you are allergic to ingredients in this product.

When Using This Product

  • Avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.
  • Do not bandage tightly.

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 or contact 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 affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: do not use, consult a doctor.

Other Information:

  • Protect the product in this container from excessive heat or direct sun. 
  • Tamper Evident Feature: do not use if damaged, broken or missing.

Inactive Ingredients:

Alpha-GFE®, Propylene Glycol, Polyethylene Glycol 400, Polyethylene Glycol 350, Cetyl Alcohol, Glyceryl Monostearate, Cre-Ester®, Colloidal Oatmeal, Dioctyl Sodium Sulfosuccinate, Sodium Hydroxide.

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