Good Neighbor Pharmacy Capsaicin
FDA Label NDC 46122-116

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 Pharmacy Capsaicin (NDC 46122-116). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                      Purpose

Capsaicin 0.1%........................................................................Topical analgesic

Otc - Purpose

For the temporary relief of minor pain associated with:

  • Arthritis
  • Simple backache
  • Muscle strains
  • Sprains
  • Bruises

Warnings

Warnings

For external use only

Otc - When Using

When using this product

  • use only as directed
  • do not bandage
  • do not use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a slight burning
  • sensation may occur upon application but generally disappears in several days
  • if severe burning occurs, discontinue use
  • do not expose the treated area to heat or direct sunlight
  • do not use if allergic to capsicum or chili peppers

Otc - Stop Use

Stop use and ask a doctor if

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

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.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions

Adults and children over 18 years:

  • apply generously to affected area not more than 3 to 4 times daily
  • massage into painful area until thoroughly absorbed
  • wash hands with soap and water after use
  • close cap tightly after use
    • Children 18 years or younger: Ask a doctor

Inactive Ingredient

Inactive ingredients

Benzyl alcohol, cetyl alcohol, citric acid, glyceryl stearate SE, isopropyl myristate, PEG 100 stearate, petrolatum, purified water, sorbitol

Dosage & Administration

Distributed By

Amerisource Bergen

1300 Morris Drive

Chesterbrook, PA 19087

Visit us at

www.goodneighborpharmacy.com


Made in Korea

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Image Of Carton Label (Gnpcapsaicincream)

Image Of Carton Label (Gnpcapsaicincream)

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