Capzasin Quick Relief Gel
FDA Label NDC 41167-7516

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Capzasin Quick Relief (NDC 41167-7516). 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, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, 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

Active Ingredient

Capsaicin 0.025%

Menthol 10%

Purpose

Topical analgesic

Topical analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

For external use only

When Using This Product

  • read inside of carton before using
  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately and read inside carton for important information
  • do not expose the area treated with product to heat or direct sunlight

Stop Use And Ask A Doctor If

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again 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 right away.

Directions

adults and children over 18 years:

  • squeeze desired amount of Capzasin Quick Relief Gel onto affected area
  • using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed
  • repeat as necessary, but no more than 3 to 4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    • children 18 years or younger: ask a doctor

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice, DMDM hydantoin, fragrance, glycerin, methylparaben, phenoxyethanol, propylene glycol, propylparaben, SD alcohol 40-2 (15%), steareth-2, steareth-21, triethanolamine, water (245-285)


KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION.


Distributed by: Chattem, Inc.
P.O. Box 2219
Chattanooga, TN 37409-0219
0049618-03       U.S.A. ©2010 www.chattem.com        Recyclable Carton



Principal Display Panel

ARTHRITIS PAIN RELIEF
CAPZASIN TM
QUICK RELIEF GEL

  • #1 Pharmacist
    Recommended*
  • Two Strong
    Pain Relievers
  • Starts to Work
    on Contact

    • NO-MESS
    Sponge Applicator
    PURIFIED
    P
    CAPSAICIN    ®
    Topical Analgesic Gel
    *SOURCE: 2009 Pharmacy Today Survey
    Net wt 1.5 oz (42.5 g)

    Principal Display Panel (Net wt 1.5 oz (42.5 g))

    Principal Display Panel (Net wt 1.5 oz (42.5 g))

* Please review the disclaimer below.