1. Home
  2. Labeler Index
  3. United Exchange Corporation
  4. 55264-269
  5. Label Information: Medicated Heat

FDA Label for Medicated Heat

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT

Medicated Heat Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange Corporation. 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

Capsicum extract 0.025 % as Capsaicin


Otc - Purpose



Purpose

Topical Analgesic



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.
  • If pregnant or breastfeeding consult a healthcare professional before use.
  • 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 damage 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 - 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.


Dosage & Administration



Directions

adults and children under 12 years of age and older

  • clean and dray 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 year 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, Polyisobuthylene, Precipitated calcium carbonate, Propylene carbonate, Quinton, Sorbitan monostearate, Titanium oxide, YS resin, Zinc oxide


* Please review the disclaimer below.