Label: TOPCARE PAIN RELIEVING 40CT- camphor menthol methyl salicylate patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 15, 2022

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  • ACTIVE INGREDIENT

    Active ingredients                                                      Purpose

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

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

  • 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.

  • 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
  • ASK DOCTOR

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

  • 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
  • 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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

  • QUESTIONS

    Questions or comments?

    Call 1-888-423-0139

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:Topco Associates LLC

    Elk Grove Village, IL 60007

    topcare@topco.com

    www.topcarebrand.com

    MADE IN SOUTH KOREA

  • PRINCIPAL DISPLAY PANEL

    15679

  • INGREDIENTS AND APPEARANCE
    TOPCARE PAIN RELIEVING 40CT 
    camphor menthol methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-679
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.012 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.057 mg  in 1 g
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-0.063 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCERYL ROSINATE (UNII: SD112V492J)  
    POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-679-4040 in 1 BOX01/09/2019
    11 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/16/2014
    Labeler - Topco Associates LLC (006935977)
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