Label: ICY COLD COOL PAIN RELIEVING- menthol, camphor gel

  • 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 22, 2017

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  • ACTIVE INGREDIENTS

    MENTHOL 3.9%

    CAMPHOR 0.4%

  • PURPOSE

    TOPICAL ANALGESIC

    COUNTER IRRITANT

  • USES

    temporary relief of

    • Arthritis
    • Backache
    • Strains/Sprains
  • WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    Do not use near eyes, mouth, mucus membranes, genitals, cuts, rashes and sores. If contact occurs, flush with cold water. Do not use with heating pad or device, or under bandages. Do not use if pregnant or breastfeeding. Please consult your physician prior to use. Do not apply to wounds or damaged skin.

  • STOP USE

    Stop use and ask a doctor if irritation persists.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If accidentally ingested, seek medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
    • Rub in thoroughly until gel is absorbed.
  • INACTIVE INGREDIENTS

    Water, Isopropyl Alcohol, Propylene Glycol, Glycerin, Carbomer, Ilex Paraguariensis Leaf Extract, Hydrated Silica, Aminomethyl Propanol, Methyl Paraben, Uncaria Tomentosa Extract, Boswelia Serrata Extract, Camphor for scent.

  • PRINCIPAL DISPLAY PANEL

    Thera Med Icy Cold Cool Pain Relieving Gel ( 16oz.)

  • INGREDIENTS AND APPEARANCE
    ICY COLD COOL PAIN RELIEVING 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71323-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.9 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    SILICON (UNII: Z4152N8IUI)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    UNCARIA TOMENTOSA WHOLE (UNII: U6P1SV66LA)  
    BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71323-101-26473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/22/2017
    2NDC:71323-101-913785 mL in 1 JUG; Type 0: Not a Combination Product03/22/2017
    3NDC:71323-101-1388.8 mL in 1 BOTTLE; Type 0: Not a Combination Product03/22/2017
    4NDC:71323-101-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/22/2017
    5NDC:71323-101-055 mL in 1 POUCH; Type 0: Not a Combination Product03/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/22/2017
    Labeler - COMPASS HEALTH BRANDS CORP. (827221698)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIVERSIFIED MANUFACTURING CORP185073996manufacture(71323-101)
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