Topcare Pain Relieving 40ct
FDA Label NDC 36800-679

14 label sections · Submitted to the FDA by Topco Associates Llc · 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 - pregnancy or breast feeding, 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:

  • sprains
  • simple backache
  • bruises
  • arthritis
  • strains

Warnings

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or slicylates, consult a doctor before use.

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
  • on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area.

Otc - When Using

When using this product

  • do not use otherwise than directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not badnage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Otc - Stop Use

Stop use and ask a doctor if

  • redness is present or irritation or rash 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 children. If swallowed, get medical help or contact a Poision Control Center (1-800-222-1222) 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
  • do not wear patch for more than 8 hours
  • children under 12 years of age: consult a doctor

Storage And Handling

Other information

  • store at room temperature 20-25°C (68-77°F)
  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive Ingredient

butylated hydroxytoluene, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, quinton, sorbitan stearate, tocopherol acetate, ys resin, zinc oxide

Dosage & Administration

DISTRIBUTED BY:Topco Associates LLC

Elk Grove Village, IL 60007

[email protected]

www.topcarebrand.com

MADE IN SOUTH KOREA

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