Label: KOOL COMFORT- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 July 5, 2012

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  • ACTIVE INGREDIENT

    Active ingredient
    Menthol 2.5%

    Purpose
    Cooling Pain relief
  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with · simple backache · arthritis ·strains · bruises · sprains
  • Warnings

    For external use only.

    Flammable
    Keep away from excessive heat or open flame.

    Ask a doctor before use if you have
    • sensitive skin

    When using this product
    • avoid contact with the eyes or mucous membranes
    • do not apply to wounds or damaged skin
    • do not use with other ointments, creams, sprays or liniments
    • do not apply to irritated skin or if excessive irritation develops
    • do not bandage
    • wash hands after use with cool water
    • do not use with heating pad or heating devices

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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Adults and children 2 years of age and over:  apply to affected area not more than 3 to 4 times daily
    • Children under 2 years of age:  Consult a physician.
  • Other information

    Store in a cool dry place with lid tightly closed.
  • Inactive ingredients

    carbopol 934, FD&C blue #1, esi-cryll ll, herbal extract (ILEX paraguariensis), isopropyl alcohol, neutrol TE, phenonip, and purified water.
  • SPL UNCLASSIFIED SECTION

    Lot. No. & Exp. Date:  See label or bottom of container.
    Manufactured for:
    Dee Cee Laboratories Inc., 304 Dee Cee Ct., White House, TN  37188
  • Product Packaging


    Kool Comfort Labeling





  • INGREDIENTS AND APPEARANCE
    KOOL COMFORT  
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52301-365
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    EDETOL (UNII: Q4R969U9FR)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52301-365-08226.79 g in 1 JAR
    2NDC:52301-365-16453.59 g in 1 JAR
    3NDC:52301-365-32907.20 g in 1 JAR
    4NDC:52301-365-782211.22 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/05/2012
    Labeler - Dee Cee Laboratories, Inc. (034731893)
    Registrant - Great Southern Laboratories (056139553)
    Establishment
    NameAddressID/FEIBusiness Operations
    Great Southern Laboratories056139553manufacture(52301-365)
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