KOOL COMFORT (MENTHOL) GEL [DEE CEE LABORATORIES, INC.]

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KOOL COMFORT (MENTHOL) GEL [DEE CEE LABORATORIES, INC.]
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NDC 52301-365-08, 52301-365-16, 52301-365-32, 52301-365-78
Set ID 996c0e13-5f36-4779-99db-b893b482597b
Category HUMAN OTC DRUG LABEL
Packager Dee Cee Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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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