Label: MEIJER COLD THERAPY PAIN RELIEF 360- cold therapy muscle 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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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Menthol 10.5% Cooling Pain Relief

  • PURPOSE

    Use

    Temporary relief of minor aches and pains of sore muscles and joints associated with arthritis, backaches, strains and springs.

  • WARNINGS

    Warnings

    For external use only

    Flammable

    Keep away from excessive heat or open flame. Contents umder pressure. Do not store at temperatures above 120ºF.

  • INDICATIONS & USAGE

    When using the product avoid contact with the eyes or mucous membranes.,do not apply to wounds or damaged skin, do

    not apply to the irritated skin or if excessive irritation develops, do not bandage, do not use with heating pad of device.

    Stop and ask a doctor if, condition worsens or if symptoms persist for more than 7 days or clear up and occur again with a few

    days

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children. Iff accidentally ingested get medical help of contacat a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions , Adults and Children 12 yearsof age and older.

    Spray on the affected areas not more that 4 times daily., massage not necessary.

    Children under 12 years of age. Consult a doctor

  • WARNINGS AND PRECAUTIONS

    Other informaton

    Store in a cool dry place with lid closed tightly

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Alcohol denat. arnica montana flower extract, calendula officinalis flower extract, camellia sinensis leaf extract, chamomillx recuitita (matricaria) flower extract, dimethyl sulfone (MSM), ecinacea angustifolia extract, ilex paraguariensis leaf extract, isopropyl myristate, juniperus communis fruit extract, water

  • QUESTIONS

    Questions 1-800-255-3924

  • PRINCIPAL DISPLAY PANEL

    Cold Therapy85 grams NDC 52313-1112-1 Cold Therapy pain relief 360º

    Topical Analgesis

    Soothing Menthol 10.5%

    Paraben Free

    For Arthritus, Sore Muscles, Back Pain and Joints.

    Vanishing Scent

    Spray at any angle.

  • INGREDIENTS AND APPEARANCE
    MEIJER COLD THERAPY PAIN RELIEF 360 
    cold therapy muscle spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52313-1112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL105 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    ALCOHOL (UNII: 3K9958V90M)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52313-1112-185 g in 1 CAN; Type 0: Not a Combination Product05/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/04/2020
    Labeler - Sklar BOV Solutions Inc (800463486)
    Registrant - Sklar BOV Solutions Inc (800463386)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sklar BOV Solutions Inc800463486manufacture(52313-1112)
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