The Black Patch
FDA Label NDC 71948-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carbon Innovation, Inc. for the product The Black Patch (NDC 71948-101). 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 ingredient (in each patch), purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Patch)

Menthol 4%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

When using this product

  • use only as directed
  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

    • Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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 and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.

Inactive Ingredients

activated charcoal, disodium EDTA, ethanol, gelatin, glycerin, polysorbate 80, polyvinyl alcohol, salt, sodium polyacrylate, tartaric acid, water

Questions Or Comments?

1-800-254-5041

Packaging

Tblkptch (B Patchbx1)

Tblkptch (B Patchbx1)

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