Cu Pain Away Pain Relief Cream
FDA Label NDC 71304-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Canadian Unique Health Ltd. for the product Cu Pain Away Pain Relief (NDC 71304-001). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 1.25%

Purpose

Counterirritant

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only. Avoid contact with the eyes and mucous membranes.

When Using This Product

  • use only as directed
  • do not apply to wounds or damaged skin
  • 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
  • irritation of the skin develops If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

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

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

  • Store in a cool dry place
  • Protect from heat and light

Inactive Ingredients

aloe (Aloe barbadensis) leaf juice, avocado (Persea gratissima) oil, caprylyl glycol, cetearyl alcohol, coco-caprylate, coconut (Cocos nucifera) oil, cupric oxide, disodium EDTA, isoamyl cocoate, isopropyl palmitate, jojoba (Simmondsia chinensis) seed oil, lavender (Lavandula angustifolia) oil, lemon (Citrus limon) oil, phenoxyethanol, polysorbate 60, silk amino acids, sodium lactate, stearic acid, tea tree (Melaleuca alternifolia) leaf oil, tocopherol

Questions Or Comments?

Call 1-844-893-3085 Monday through Friday, 9-5pm EST or visit www.canadianunique.com

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