Walgreens Capsaicin Hot
FDA Label NDC 0363-9113

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co for the product Walgreens Capsaicin Hot (NDC 0363-9113). 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 - pregnancy or breast feeding, otc - do not use, otc - when using, otc - stop use, otc - 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

Otc - Active Ingredient

Active ingredient                                                                                   Purpose

Capsaicin extract 0.025% as Capsaicin.....................................Topical Analgesic

Otc - Purpose

Uses Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

Warnings

  • For external use only
  • Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower
  • Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding consult a healthcare professional before use.

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with, or at the same time as, other external analgesic products

Otc - When Using

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes or rashes

Otc - Stop Use

Stop use and ask a doctor if

  • conditions worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days
  • rash, itching or excessive skin irritation develops

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.

Indications & Usage

Directions

  • Adults and children 12 years of age and older:
  • clean and dry affected area
  • remove patch from film
  • apply to affected area no more than 3 to 4 times daily for 7 days
  • remove patch from the skin after at most 8 hours application
  • Children under 12 years of age: consult a doctor

Storage And Handling

Other information

  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive Ingredient

Inactive ingredients BHT, Ester gum, isopropyl myristate, natural rubber, polybutene, polysobutylene, precipitated calcium carbonate, propylene carbonate, quinton, sorbitan monostearate, titanium dioxide, YS resin, Zinc oxide

Dosage & Administration

Distributed By:

Walgreen Co

200 Wilmot Rd.

Deerfield, IL 60005

Made in Korea

* Please review the disclaimer below.