Label: C.D.M.A ICY COOL- 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 Purpos

    Menthol 10.5% Topical Analgesic

  • PURPOSE

    Uses - Topical Analgesic

  • INDICATIONS & USAGE

    INDICATIONS AND USAGE

    Temporary relief form minor aches and pains of sore muscles and joints associated with arthritis backache, strains and sprains

  • WARNINGS

    Warning

    FOR EXTERNAL USE ONLY. Flammaable. Keep away form excessive heat of open flame. CONTENTS UNDER

    PRESSURE. DO NOT PUNCTURE OR INCINERATE. DO NOT STORE AT TEMPERATURE ABOVE 120°F.

  • WARNINGS AND PRECAUTIONS

    When using this product; Avoid contact with eyes or mucous membranes. Do not apply to wounds or damages skin.

    Do not use with others sprays, ointments, creams, sprays of liniments. Do not apply to irritated skin or if excessive

    irritation develops. Do not bandage. Wash hands after use with cold water. Do not use with heating pad or device.

  • STOP USE

    Stop Use and Ask a Doctor if: Condition worsens. If symptoms persist for more than 7 days, of if symptons clean up and

    reoccur.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children. If swallowed, het medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If Pregnant of Breastfeeding; Consult a doctor before use.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and Children 12 years of age and older. Spray on the affected areas not more than 4 times daily, massage not

    necceeary. Children under 12 years of age, Consult Physicial

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Inactive Ingredients: Alcohol Denat., Arnica Montana Flower Extract. Calendula Officinalis Flower Extract, Camellia

    Sinensis Leaf Extract, Chamomilla Recultita (Matricana) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Augustifola

    Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

  • QUESTIONS

    Distributed by C.D.M.A. Inc.©

    43157 W 9 Mile Rd

    Novi, NI 48375

    www.qualitychoice.com

    Questions: 248-449-9300

  • PRINCIPAL DISPLAY PANEL

    Icy Cool Label85 grams NDC52313-1131-1

    Maximum Strength

    Icy Cool™

    Pain Relieving Spray

    Menthol 10.5 % | Topical Analgesic

    Relief from Aches and Pains Associated with Strains, Sprains, Simple Bachaches, Bruses and Arthritus

    Quatity Choice®

  • INGREDIENTS AND APPEARANCE
    C.D.M.A ICY COOL 
    cold therapy muscle spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52313-1131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM105 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52313-1131-185 g in 1 CAN; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/23/2020
    Labeler - Sklar BOV Solutions Inc (800463486)
    Registrant - Sklar BOV Solutions, Inc (800463486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sklar BOV Solutions, Inc800463486manufacture(52313-1131)
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