Painfix Restore
FDA Label NDC 72749-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Painfix Llc for the product Painfix Restore (NDC 72749-000). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., 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

Active Ingredients

Menthol 3%

Purpose

`Topical analgesic

Uses

Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonits • cramps • strains • bruises • sprains

Warnings

Avoid direct contact with eyes. For external use only.

When Using This Product

• use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin

Stop Use And Ask A Doctor If

• condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

Adults and children above 12 years:

  • open pouch and remove patch
  • peel off protective backing and carefully apply sticky side to affected area
  • if affected area is large, use more than one patch for best results
  • use each patch for up to 15 hours
  • apply a new patch each day
  • to better keep the patch in place, use the provided adhesive plasters
  • for best results, use with recommended exercises

    • Children 12 years and younger, ask a health professional

Other Information

Store in a cool, dry place, away from direct sunlight.

Ingredients

Aloe barbadensis extract, Aluminum glycinate, Angelica anomala extract, Carthamus tinctorius extract, Cinnamomum camphora extract, Cinnamomum cassia extract, Citrus reticulata extract, Commiphora molmol extract, Curcuma longa extract, Curcuma zedoaria extract, Daemonops draco extract, Disodium EDTA, Drynaria fortunei extract, Glycerine, Glyceryl stearate, Kaolin, Methylparaben, PEG-40 hydrogenated castor oil, Pistacia lentiscus extract, Polyvinylpyrrolidone, Rheum officinale extract, Sodium polyacrylate, Scutellaria baicalenis extract, Tartaric acid, Water (Aqua)

Package Labeling:

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