Label: MEIJER COLD AND HOT THERAPY- menthol, methyl salicylate cream

  • 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

    Menthol 10%.................................................Topical Analgesic

    Methyl Salicylate 30%...................................Topical Analgesic

  • PURPOSE

    Uses

    temporarily relieves minor pain associated with:

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

  • WARNINGS

    Warnings

    For external use only

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

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
  • WHEN USING

    When using this product

    • ​avoid contact with eyes or mucous membranes
    • do not bandage tightly
  • ASK DOCTOR

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
    • redness of the skin is present
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions

    use only as directed

    adults and children 12 years of age and older:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but not more than 4 times daily

    childen under 12 years of age: ask a doctor

  • DOSAGE & ADMINISTRATION

    Other Information

    • store at room temperature 20-25ºC (68-77ºF)
  • INACTIVE INGREDIENT

    Inactive ingredients carbomer, cetostearyl alcohol, cetyl esters wax, polysorbate 60, purified water, steareth-20, stearic acid, trolamine

  • PRINCIPAL DISPLAY PANEL

    1234

  • INGREDIENTS AND APPEARANCE
    MEIJER COLD AND HOT THERAPY 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-858
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-858-351 in 1 CARTON07/02/2020
    135 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 finalpart34807/02/2020
    Labeler - Meijer, Inc. (006959555)
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