Label: TOPCARE MAXIMUM STRENGTH PAIN RELIEVING ANALGESIC- menthol, unspecified form liquid

  • 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 January 27, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 16%

  • Purpose

    Topical analgesic

  • Uses

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

    ♦
    simple backache
    ♦
    arthritis
    ♦
    strains
    ♦
    bruises
    ♦
    sprains
  • Warnings

    For external use only. Test on a small patch of skin before applying generously.

    When using this product

    ♦
    use only as directed
    ♦
    avoid contact with the eyes and mucous membranes
    ♦
    do not apply to wounds or damaged skin
    ♦
    do not bandage tightly
    ♦
    do not use with heating pads or other heating devices
    ♦
    if redness is present, discontinue use and consult a doctor
    ♦
    if skin irritation occurs, discontinue use
    ♦
    a transient burning sensation may occur upon application but generally disappears in several days

    Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Flammable

    ♦
    keep away from fire or flame

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800222-1222) immediately.

  • Directions

    adults and children 12 years of age and older:

    ♦
    apply generously to affected area
    ♦
    massage into painful area until thoroughly absorbed into skin
    ♦
    repeat if necessary, but not more than 3 to 4 times daily
    ♦
    IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

    Children 12 years or younger: ask a doctor

  • Other information

    store at room temperature

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.

  • Questions or comments?

    1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

    NDC 36800-894-01

    TopCare
    health®

    COMPARE TO ICY HOT® ACTIVE INGREDIENT*

    MAXIMUM STRENGTH

    Cool n' Heat
    Roll-On Liquid

    External Analgesic
    with Menthol 16%

    STAIN FREE

    • Powerful, Fast &
      Effective Pain Relief
    • No-Mess Applicator
    • Keeps Hands Clean

    OUR PHARMACISTS
    RECOMMEND

    2.5 FL OZ (74 mL)

    PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TOPCARE MAXIMUM STRENGTH PAIN RELIEVING   ANALGESIC
    menthol, unspecified form liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-894
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Alcohol (UNII: 3K9958V90M)  
    Capsaicin (UNII: S07O44R1ZM)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-894-011 in 1 CARTON03/25/2020
    174 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/25/2020
    Labeler - Topco Associates LLC (006935977)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(36800-894)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!