Scalar Pain Relief Cream
FDA Label NDC 80883-097

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Miracle Balance, Llc for the product Scalar Pain Relief Cream (NDC 80883-097). 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:, warning:, do not use:, when using this product:, stop use and as 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.

Active Ingredients

Menthol 5%

Purpose

Topical Analgesic

Uses:

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

Warning:

For external use only

Do Not Use:

- On damaged or broken skin

When Using This Product:

  • Avoid contact with the eyes
  • Do not bandage tightly

Stop Use And As A Doctor If:

  • rash or irritation develops and lasts.
  • 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 Breast-Feeding,

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:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Ceteareth-20, Cyclopentasiloxane, Cyclotetrasiloxane, Ethylhexylglycerin, Juniperus Communis (Juniper Berry) Extract, magnesium Chloride, Methyl Glucose Sesquistearate, Methyl Salicylate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Solidago Virgaurea (Goldenrod) Extract, Spiraea Ulmaria (Meadowsweet) Extract, Steareth-2, Steareth-10, Stearic Acid, Taraxacum Officinale (Dandelion) Extract, Vitis Vinifera (Grape) Seed Oil.

Questions Or Comments?

PH: 806-625-0087 or www.scalarshop.com This product is manufacetured for: Miracle Balance, LLC, Delray Beach FL 33483

Package Labeling:

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