Picklebalm Lidocaine With Menthol Arnica Cucumber Seed Balm Stick
FDA Label NDC 71323-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Compass Health Brands Corp. for the product Picklebalm Lidocaine With Menthol Arnica Cucumber Seed Balm (NDC 71323-201). 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 drug facts, active ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Lidocaine 4%

Menthol 1%

Purpose

Topical analgesic

Use

  • For the temporary relief of pain

Warnings

For external use only

When Using This Product

  • Avoid contact with eyes
  • Do notuse in large quantities, particularly over raw or blistered areas
  • Do notapply to wounds or damaged skin
  • Do notbandage tightly

Stop Use And Ask A Doctor If

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

Directions

Adults and children 12 years of age and older:apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: ask a doctor.

Other Information

  • Store at 15° to 30°C (59° to 86°F)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Butylene/Ethylene/Styrene Copolymer, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Cetearyl Alcohol, Cetyl Alcohol, Cucumis Sativa (Cucumber) Extract, Dimethicone, Ethylene/Propylene/Styrene Copolymer, Fragrance, Glycerin, Glyceryl Sterate, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated poly (C6-14 Olefin), Ozokerite, Paraffin, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polymethylsilsesquioxane, Sodium Stearoyl Lactylate, Stearyl Alcohol, Synthetic Beeswax, Tapioca Starch, Tocopheryl Acetate, Tribehenin, Theobroma Cacao Seed Butter, Water.

Questions?

Call 800.376.7263

Package Labeling:

Label5 (Label5)

Label5 (Label5)

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