Label: THERAPEUTIC ICY COLD COOLING PAIN RELIEF- menthol 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 November 23, 2019

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  • ACTIVE INGREDIENT

    NATURAL MENTHOL 3.9%

  • PURPOSE

    COOLING PAIN RELIEF

  • USES

    TEMPORARY RELIEF OF

    • ARTHRITIS
    • BACKACHE
    • STRAINS/SPRAINS
  • WARNINGS

    FOR EXTERNAL USE ONLY.

    DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, 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 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, SD ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT (YERBA MATE), HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT (CAT'S CLAW), BOSWELIA SERRATA EXTRACT, CAMPHOR FOR SCENT

  • PRINCIPAL DISPLAY PANEL

    ICY COLD Cooling Pain Relief_Topical Gel

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC ICY COLD  COOLING PAIN RELIEF
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69851-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    UNCARIA TOMENTOSA LEAF (UNII: 487U8M3D2P)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69851-103-34118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/15/2015
    Labeler - APEX-CAREX HEATHCARE PRODUCTS (622368947)
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