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  5. Label Information: Topcare Pain Relieving 40ct

FDA Label for Topcare Pain Relieving 40ct

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. INDICATIONS & USAGE
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. DOSAGE & ADMINISTRATION
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topcare Pain Relieving 40ct Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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 ingredients                                                      Purpose

Camphor 1.2%....................................................... Topical Analgesic
Menthol 5.7%......................................................... Topical Analgesic

Methyl Salicylate 6.3%............................................. Topical Analgesic


Otc - Purpose



Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

  • on wounds or damaged skin
  • if you are allergic to asprin or salicytes
  • with a heating pad
  • with, or at the same time as, other external analgesic products

Otc - Ask Doctor



Ask a doctor before use, if you are allergic to any ingredients of this product


Otc - When Using



When using this product

  • do not use otherwise than directed
  • avoid contact with the eyes, mucous membranes or rashes

Otc - Stop Use



Stop use and ask a doctor if

  • rash itching or excessive skin irritation develops
  • conditions worsen symptoms persist for more than 7 days
  • symptoms clear up and occur again withing a few days

Otc - Keep Out Of Reach Of Children



Keep out of the reach of childre. If swallowed, get medical help or contact a Poision Control Center right away.


Indications & Usage



Directions

Adults and children 12 years of age and over:

  • 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 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 from excessive moisture

Inactive Ingredient



Inactive ingredients Butylated Hydroxytoluene, Hydrogenated Rosin Glycerol Ester, Maleated Rosin Glycerin Ester, Natural Rubber, Perfume, Polybutene, Polyisobutylene, Silicon Dioxide, Starch Grafted Acrylate, Titanium Dioxide, Tocopherol Acetate, Zinc Oxide


Dosage & Administration



DISTRIBUTED BY:

Topco Associates LLC

150 Northwest Point Boulevard

Elk Grove Village, IL 60007


* Please review the disclaimer below.