Meijer Capsaicin
FDA Label NDC 41250-256

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Meijer Capsaicin (NDC 41250-256). 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

Uses

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, isopropyl myristate, polyoxyl 40 stearate, purified water, sorbitan, monostearate, sorbitol solution, white petrolatum

Dosage & Administration

DIST. BY MEIJER DISTRIBUTION, INC.

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.com

Made in Korea

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Image Description (25352.1)

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