FDA Label for Meijer Medicated Heat

View Indications, Usage & Precautions

Meijer Medicated Heat Product Label

The following document was submitted to the FDA by the labeler of this product Meijer. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient                                                                                 Purpose

Capsicum 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 - 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

Otc - Stop Use



Stop use and ask a doctor if

  • condition 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 - Pregnancy Or Breast Feeding



If pregnant or breastfeeding consult a healthcare professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swollen, 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 not 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, Polyisobutylene, Precipitated calcium carbonate, Propylene carbonate, Quinton, Sorbitan monostearate, Titanium dioxide, YS resin, Zinc oxide


Dosage & Administration



Distributed By:

Meijer Distribution Inc.

2929 Walker Ave

Grand Rapids, MI 49544

Made in Korea


Package Label.Principal Display Panel




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