Label: MEIJER EXTRA STRENGTH COLD AND HOT THERAPYPAIN RELIEVING TOPICAL ANALGESIC- menthol, unspecified form and methyl salicylate cream

  • NDC Code(s): 41250-378-01
  • Packager: Meijer Distribution, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Menthol 10%Topical analgesic
    Methyl Salicylate 30%Topical analgesic
  • Uses

    temporarily relieves minor pain associated with:

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

    For external use only

    Test on a small patch before applying generously.

    Allergy alert

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using this product

    • use only as directed. Read and follow all directions and warnings on this label
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • a transient burning sensation may occur upon application but generally disappears in seven days

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • irritation develops
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children over 12 years:

    • apply to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 4 times daily
    • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

    Children 12 years or younger: ask a doctor

  • Other information

    Keep tightly closed. Store at room temperature.

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, carbomer, ceteareth-20, cetearyl alcohol, oleth-3 phosphate, phenoxyethanol, polysorbate 60, sodium hydroxide, stearic acid, water.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544

  • PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

    Compare to
    Icy Hot®Active
    Ingredients*

    meijer®

    EXTRA STRENGTH
    cold & hot therapy

    Menthol 10% (Topical Anangesic)
    Methyl Salicylate 30% (Topical Anangesic)

    Pain Relieving Cream

    Body & Backache | Bruises | Arthritis | Sore Muscles

    NET WT 1.25 OZ (35.4 g)

    PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MEIJER EXTRA STRENGTH COLD AND HOT THERAPYPAIN RELIEVING   TOPICAL ANALGESIC
    menthol, unspecified form and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-378
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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 Salicylate300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-378-011 in 1 CARTON11/30/2020
    135.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01711/30/2020
    Labeler - Meijer Distribution, INC (006959555)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(41250-378)
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