Hot And Cold Lidocaine With Menthol Patch
FDA Label NDC 76168-099

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma Llc for the product Hot And Cold Lidocaine With Menthol Patch (NDC 76168-099). 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, otc - purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, 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

Other

Drug Facts

Otc - Purpose

Active IngredientsPurpose
Lidocaine 4 %Topical analgesic
Menthol 1%Topical analgesic

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warnings

For external use only.

Otc - Do Not Use

Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.

When Using This Product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not apply to open wounds or sensitive skin
  • do not bandage tightly or use a heating pad

Stop Use And Ask A Doctor If

  • excessive redness or irritation is present
  • condition worsens
  • pain persists for more than 7 days
  • symptoms clear up and occur again within a few days

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 right away.

Directions

  • adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
  • children: consult your physician
  • remove protective film, gently apply to affected area.

Inactive Ingredients

aluminium hydroxide gel, bentonite, borax, carbomer, carboxymethylcellulose sodium,
colloidal silicon dioxide, dihydroxyaluminumaminoacetate, disodiumedetate, gelatin, glycerin, oleic acid, polysorbate 80, polyvinyl Alcohol, potassium Sorbate, povidone, propylene glycol, sodiummetabisulphite, tartaric acid, trolamine, urea, water

Principal Display Panel - 3 Topical Patch Carton

CONTAINS LIDOCAINE with Menthol

PAIN RELIEF PATCH

5TOPICAL PATCHES PER BOX

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