Amino Active Topical Analgesic Cream
FDA Label NDC 82908-357

Full FDA labeling including 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 Active Topical Analgesic Cream (NDC 82908-357). 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 ingredients, purpose, uses:, warnings:, do not, 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 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:

Label (Label)

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