Pain Relief 4% Lidocaine Patch
FDA Label NDC 71391-151

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unexo Life Sciences Private Limited for the product Pain Relief 4% Lidocaine (NDC 71391-151). 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 other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Manufactured By:

UNEXO LIFE SCIENCES PVT. LTD.
B-16. Sector 4, Bawana Industrial Area,
Delhi – 110039 (INDIA)

Active Ingredient

Lidocaine 4.0%

Purpose

Topical anesthetic

Uses

Temporarily relieves minor pain.

Warnings

For external use only

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 pack
  • 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 Ask A Doctor If

  • 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 breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use

  • Children 12 years of age or younger: Consult a physician.

Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

aluminum glycinate, benzyl alcohol, ethylhexylglycerin, glycerin, kaolin, methylparaben, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions Or Comments

Call +91 9212228401

Principal Display Panel - One Patch Pouch

NDC: 71391-151-01

PAIN RELIEF
4% LIDOCAINE PATCH

Desensitizes aggravated nerves
and relieves pain

No-mess
Single-use application
Easy to apply and remove
Stay-put flexible gel patch
Unscented

1 PATCH
3.93 X 5.51 IN
(10cm X 14cm)

Principal Display Panel (One Patch Pouch)

Principal Display Panel (One Patch Pouch)

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