Good Neighbor Capsaicin Heat Patch For Back Patch
FDA Label NDC 46122-753

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Good Neighbor Capsaicin Heat Patch For Back (NDC 46122-753). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Capsicum extract 0.025% as Capsaicin

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • minor backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do Not Use

ALLERGY ALERT:

If you are allergic or suspect you are allergic to the ingredients of this product,
including chili peppers, consult with your physician before use.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When Using This Product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Stop Use And Ask A Doctor If

  • skin reactions such as redness, rash, itching, excessive irritation burning sensation, swelling or blistering occurs ■ condition worsens ■ symptoms persist more
    than 7 days ■ symptoms clear and reoccur within a few days.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • use one patch for up to 8 hours
  • discard patch after single use

    • Children under 12 years of age: consult a physician

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients

hydrogenated C6-20 polyoleon, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate,
petroleum, styrene/isoprene copolymer

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