Smartrx Natural Pain Relief Sleeve Back
FDA Label NDC 60589-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Niche Brands, Inc. for the product Smartrx Natural Pain Relief Sleeve Back (NDC 60589-002). 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 smartrx natural pain relief sleeve back, active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Smartrx Natural Pain Relief Sleeve Back


Active Ingredient

Methyl Salicylate 10%

Purpose

External Analgesic (Counterirritant)

Use

for the temporary relief of minor aches and pains of muscles and joints associated with • arthritis • strains • bruises • sprains.

Warnings

For external use only. Avoid contact with the eyes.

When Using This Product

  • Do not use otherwise than as directed.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use in conjunction with liniments, balms or lotions.
  • Do not use on damaged or broken skin.

Stop Use And Ask A Doctor If

  • Redness is present.
  • Excessive irritation of skin develops.
  • Condition worsens, or if symptoms persist for more than 7 days.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

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

Directions

Open pouch and remove. Pull woven sleeve containing external analgesic pads over ankle, positioning on either side of affected area.

  • Adults and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
  • Children under 3 years of age: Consult a physician.

Other Information:

  • Store away from direct sunlight.
  • For your protection, this sleeve has been sealed in an aluminum pouch.
  • Do not use if tamper evident seal is missing, tampered, broken or destroyed.

Allergy Warning:

Contains Macadamia nut oil.

Inactive Ingredients

Macadamia nut oil, citronella oil, mandarin oil, coriander oil and rosemary oil.

Questions?:

000-000-0000

Product Lable

Back Sleeve (Backsleeve)

Back Sleeve (Backsleeve)

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