Label: MEIJER MEDICATED COLD AND HOT PAIN RELIEVING- cold and hot spray

  • 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 31, 2022

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  • PURPOSE

    Use

    Temporarly releaves minor aches and pains of muscles and joints associated wotj artjrotos, , simple backaches, strains, bruses,

    and sprains

  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Menthol 16% Topical Analgesic

  • WARNINGS

    Warnings

    For external use only

    Flammable

    Keep away for from fire or flame. Do not puncture or incinerate.

    Contents under pressure. Do not store at temperatures above 120ºF.

  • INDICATIONS & USAGE

    When using this product, avoid contact with eyes and mucouse membranes.

    Do not apply to wounds or damaged skin

    Do not bandage tightly

    Use only as directed

    Stop use and ask a doctor if condition worsens, symptoms presist for more than 7 days, or clears up and occur again within

    a few days.

    needed for more that a weekl

    If pregnant or breastfeeding ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions , Adults and Children over 12 years old

    Spray affected area with desired amount of product,

    Repeat at needed but no more that 3 - 4 times dailiy

    Children 12 years of younger.

    Consult a physician

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Alcohol denat. glycerin, propylene glycol, water

  • KEEP OUT OF REACH OF CHILDREN

    Keep our of reach of Children. If ingested get medical help or contact a Poison Control Center immediatly

  • QUESTIONS

    Questions 1-800-255-3924

  • PRINCIPAL DISPLAY PANEL

    Cold and Hot Label113 g NDC52313-1110 Meijer Medicated Cold & Hot Pain Relieving

    Menthol 16%

    Quick Drying | Vanishing Scent

    Non-Greasy

    Sprays at any angle

    Pain Relief Therapy for

    Arthritis, Backache

    Muscle Strains and Springs

  • INGREDIENTS AND APPEARANCE
    MEIJER MEDICATED COLD AND HOT PAIN RELIEVING 
    cold and hot spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52313-1110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52313-1110-1113 g in 1 CAN; Type 0: Not a Combination Product05/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/05/2020
    Labeler - Sklar BOV Solutions Inc (800463486)
    Registrant - Sklar BOV Solutions Inc (800463486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sklar BOV Solutions Inc800463486manufacture(52313-1110)
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