Amp Relief Pain Relief Cream
FDA Label NDC 82560-273

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coastal Formulas Llc for the product Amp Relief Pain Relief Cream (NDC 82560-273). 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 active ingredients, purpose, uses:, warnings:, do not use, when using thsi product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 8.00%

Purpose

Topical Analgesic

Uses:

  • For the temporary relief of minor aches and pains of muscles and joints, associated with backache, arthritis, strains, bruises and sprains

Warnings:

For external use only.

Do Not Use

  • on damaged or broken skin

When Using Thsi Product

  • Avoid contact with the eyes.
  • Do not bandage tightly.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts
  • condition worsens 
  • symptoms persist for more than 7 days 
  • clears up and occurs 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 Breast-Feeing,

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

    • Flammable:

    • Keep away from excessive heat or open flame.

Inactive Ingredients:

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Isopropyl Myristate, Methyl Salicylate, Paraffinum Liquidum, Phenoxyethanol, Polysorbate-80, SD-Alcohol 40B Triethanolamine, FD&C Blue #1, FD&C Yellow #5

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