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Kool Comfort (Dee Cee Laboratories, Inc.)

Available Formats

Dosage Form Package Information Links
GEL 226.79 g in 1 JAR (52301-365-08) Label Information
GEL 2211.22 g in 1 JAR (52301-365-78) Label Information
GEL 907.2 g in 1 JAR (52301-365-32) Label Information
GEL 453.59 g in 1 JAR (52301-365-16) Label Information

Complete Kool Comfort Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:52301-365
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 2.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER 934 (UNII: Z135WT9208)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    EDETOL (UNII: Q4R969U9FR)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52301-365-08 226.79 g in 1 JAR
    2 NDC:52301-365-16 453.59 g in 1 JAR
    3 NDC:52301-365-32 907.20 g in 1 JAR
    4 NDC:52301-365-78 2211.22 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/05/2012
    Labeler - Dee Cee Laboratories, Inc. (034731893)
    Registrant - Great Southern Laboratories (056139553)
    Establishment
    Name Address ID/FEI Business Operations
    Great Southern Laboratories 056139553 manufacture(52301-365)