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Kool Comfort Pain Relieving Roll-On (Wonder Laboratories)

Available Formats

Dosage Form Package Information Links
LOTION 100 g in 1 BOTTLE, WITH APPLICATOR (99528-3590-3) Label Information

Complete Kool Comfort Pain Relieving Roll-On Information

  • ACTIVE INGREDIENT

    Active Ingredient:                                                                     Purpose

    Natural Menthol USP 3.5%....................................................Cooling Pain Relief


  • PURPOSE

    Uses:  Temporary relief of minor aches and pains of sore muscles and joints

    associated with - arthritis - backache - strains - sprains


  • WARNINGS

    Warnings:  For external use only

    Flammable:  Keep away from excessive heat or open flame


  • ASK DOCTOR

    Ask a doctor before use if you have: Sensitive Skin


  • INDICATIONS & USAGE

    When Using This Product: Avoid contact with 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

    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


  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding:  Ask a health professional before use.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:  If accidentally ingested, get medical help or contact a Poison Control Center right away


  • DOSAGE & ADMINISTRATION

    - Adults and children 2 years of age and older:  Roll on to the affected areas not more than 4 times daily; massage not necessary

    - Children under 2 years of age:  Consult a physician


  • STORAGE AND HANDLING

    Other Information:  Store in a cool dry place with lid tightly closed


  • INACTIVE INGREDIENT

    Inactive Ingredients: carbomer, FDC blue #1, FDC yellow #5, , glycerine, herbal extract (ILEX paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol USP, silicon dioxide, triethanolamine USP, water


  • INGREDIENTS AND APPEARANCE
    KOOL COMFORT PAIN RELIEVING ROLL-ON 
    menthol lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:99528-3590
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 3.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Camphor (Synthetic) (UNII: 5TJD82A1ET)  
    Trolamine (UNII: 9O3K93S3TK)  
    Product Characteristics
    Color green (mint green) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:99528-3590-3 100 g in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/01/2009
    Labeler - Wonder Laboratories (078294223)
    Registrant - U.S. Pharmaceuticals (009248480)
    Establishment
    Name Address ID/FEI Business Operations
    U.S. Pharmaceuticals, Inc. 009248480 manufacture