Family Care Back Pain Therapy
FDA Label NDC 65923-901

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp for the product Family Care Back Pain Therapy (NDC 65923-901). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active IngredientsPurpose
Camphor 80mg / patchTopical Analgesic
Menthol 24mg / patchTopical Analgesic
Capsicum Extract 16mg / patchTopical Analgesic

Otc - Purpose

Uses

For temporary relief of pains.

Warnings

Warnings

FOR EXTERNAL USE ONLY

Otc - When Using

When using this product
  • Use only as directed
  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • Do not use 1 hour prior to bathing or 30 minutes after bathing

Otc - Stop Use

Stop use and ask a doctor if
  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Indications & Usage

Directions
  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years, consult doctor before use
  • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
    • Reseal pouch containing unused patches

Storage And Handling

Other Information

This product may cause allergic reaction in some individuals. Store in cool dry place away from direct sunlight.

Inactive Ingredient

Inactive Ingredients

Aluminium glycinate, eucalyptus oil, glycerin, kaolin, mentha oil, polysorbate 80, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, polyacrylic acid solution, sorbitol solution, hydrotalcite, water

Dosage & Administration

Distributed By:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703


MADE IN KOREA

Package Label.Principal Display Panel

Image Of Carton Label (Fcbackpaintherapypatch)

Image Of Carton Label (Fcbackpaintherapypatch)

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