Label: ICEQUAKE COLD HOT- menthol patch

  • 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 March 11, 2019

If you are a consumer or patient please visit this version.

  • WARNINGS

    For External Use Only.

  • ACTIVE INGREDIENT

    Active Ingredient ...............................................................................................Purpose
    Menthol 5%...............................................................................................Topical Analgesic

  • INACTIVE INGREDIENT

    Aluminium glycinate,1,3-buthylene Glycol, Carboxymethylcellulose Sodium, Concentrated Glycerin, diethylene Glycolmonoethyl Ether, Disodium Edetate, Methyl Parahydroxybenzoate, Polyacrylic Acid Solution, Polysorbate 80, Propyl Parahydroxybenzoate, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Oxide

  • INDICATIONS & USAGE

    Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis<br />■ muscle strains ■ muscle sprains ■ bruises ■ cramps

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and over: Carefully remove backing from patch.

    Apply one patch to affected area

    Repeat as necessary, but no more than 4 times daily.

    Children under 12 years of age: Ask a doctor.

  • PURPOSE

    Topical Analgesic

  • When using this product

    Use only as directed

    ■ Do not bandage tightly.

    ■ Do not use a heating pad.

    ■ Avoid contact with eyes and mucous membranes.

    ■ Don’t apply to wounds or damaged skin.

    ■ Do not use if you are alergic to any ingredients of this product.

  • Stop use and ask a doctor

    ■ If condition worsens

    ■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

    ■ If redness is present

    ■ If irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • If pregnant or breastfeeding

    ask a health professional before use.

  • PRINCIPAL DISPLAY PANEL

    Southern Sales Services Inc
    Pembroke Pines, FL 33332

    Patch Label Image
  • INGREDIENTS AND APPEARANCE
    ICEQUAKE COLD HOT 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIETHYLENE GLYCOL (UNII: 61BR964293)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-010-044 in 1 BOX03/01/2019
    19 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2019
    Labeler - Southern Sales & Service, Inc. (013114906)