Topcare Pain Relieving 40ct
FDA Label NDC 36800-679

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Pain Relieving 40ct (NDC 36800-679). 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 - do not use, otc - ask doctor, 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 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.