Label: THERMACARE ULTRA- camphor, capsicum oleresin, menthol, methyl salicylate cream

  • NDC Code(s): 0573-3023-11, 0573-3023-14
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

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 March 22, 2021

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  • Active Ingredients

    Camphor 3.1%

    Capsicum oleoresin (equivalent to 0.025% capsaicin)

    Menthol 10%

    Methyl salicylate 15%

  • Purposes

    Topical analgesic

    Topical analgesic

    Topical analgesic

    Topical analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with:

    arthritis
    simple backache
    sprains
    strains
    bruises
  • Warnings

    For external use only

    avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

    Do not use

    on wounds or damaged skin
    with a heating pad
    if you are allergic to any ingredients of this product

    Ask a doctor before use if you have

    redness over the affected area

    When using this product

    do not bandage tightly

    Stop use and ask a doctor if

    condition worsens or if symptoms last for more than 7 days
    symptoms clear up and occur again within a few days
    rash, itching or skin irritation develops

    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 right away.

  • Directions

    use only as directed
    when first opening the tube, remove the cap then peel away the foil seal. Close the cap then use the flip-top to dispense the product.
    adults and children 12 years and older: apply to affected area not more than 3 to 4 times daily
    children under 12 years of age: consult your doctor
    wash hands after applying
  • Other information

    store at 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer, cetyl alcohol, cetyl esters wax, emulsifying wax, oleth-3-phosphate, purified water, stearic acid, trolamine

  • Questions or comments?

    Call toll-free 1-800-323-3383

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL

    NDC 0573-3023-11

    NEW

    ThermaCare®

    4 POWERFUL
    PAIN FIGHTING
    INGREDIENTS

    ULTRA
    PAIN
    RELIEVING
    CREAM

    Arthritis & Joint Pain
    Back & Body Aches
    Sprains & Strains
    Sore Muscles

    Deep
    Penetrating
    Relief of
    Tough Pain

    NET WT 2.5 OZ (70.9 g)

    PRINCIPAL DISPLAY PANEL - 70.9 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    THERMACARE ULTRA 
    camphor, capsicum oleresin, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-3023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)31 mg  in 1 g
    CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN0.25 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE ((off white)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-3023-111 in 1 CARTON07/02/201801/31/2022
    170.9 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0573-3023-141 in 1 CARTON07/02/201801/31/2022
    2113.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/02/201801/31/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)