Rugby Pain Relief Patches Patch
FDA Label NDC 0536-1202

14 label sections · Submitted to the FDA by Rugby Laboratories · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Pain Relief Patches (NDC 0536-1202). 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, indications and usage, warnings, do not use, when using this product, stop use and consult a doctor, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

External Analgesic

Indications And Usage

Temporarily relieves minor pain.

Do Not Use

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

When Using This Product

■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

■ do not use at the same time as other topical analgesics

■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ do not microwave

■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use And Consult A Doctor

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Keep Out Of Reach Of Children And Pets.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage And Administration

Adults and children 12 years of age and over:

  • Clean and dry affected area, free of lotions, ointments and creams
  • Carefully remove backing from patch starting at a corner
  • Apply sticky side of patch to affected area
  • Do not use more than one patch in an 8 hour period
  • Maximum 3 patches per day
  • Discard patch after single use

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. Dispose of used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Inactive Ingredients

aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

Questions

Call toll-free 1-866-326-1313

Package Label.Principal Display Panel

Label (50911100 Pkg For Dailymed)

Label (50911100 Pkg For Dailymed)

Label (9250002 0626 Pouch Lidocaine Patch 5ct Ndc 0536120215)

Label (9250002 0626 Pouch Lidocaine Patch 5ct Ndc 0536120215)

Box (9250001 0626 Pkg Lidocaine Patch 5ct)

Box (9250001 0626 Pkg Lidocaine Patch 5ct)

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