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
  • 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 21, 2022

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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 NOT FINALpart34811/30/2020
    Labeler - Meijer Distribution, INC (006959555)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(41250-378)
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