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Tact Cool (Sato Pharmaceutical Co., Ltd.)

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GEL 1 TUBE in 1 CARTON (49873-704-01) > 20 g in 1 TUBE Label Information

Complete Tact Cool Information

  • ACTIVE INGREDIENT

    Active ingredients

    Diphenhydramine Hydrochloride 2.0%   
    l-Menthol 1.0%


  • INDICATIONS & USAGE

    Uses

    temporarily relieves pain and itching associated with
    â– insect bites    â– minor skin irritations    â– minor cuts
    â– scrapes    â– rashes due to poison ivy    â– sunburn    â– minor burns


  • WARNINGS

    Warnings
    For external use only

    When using this product
    â– avoid contact with the eyes

    Stop use and ask a doctor if
    â– condition worsens    â– symptoms persist for more than 7 days.
    â– symptoms clear up and occur again within a few days.

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


  • DOSAGE & ADMINISTRATION

    Directions
    â– Adults and children 2 years and over: Apply to affected area not more than 3 to 4 times daily.  â– Children under 2 years: Ask a doctor.


  • INACTIVE INGREDIENT

    Inactive ingredients  alcohol, BHT, carboxyvinyl polymer, hydroxypropyl cellulose, monoethanolamine, nonoxynol 9, polysorbate 80, propylene glycol, purified water.


  • PURPOSE

    Diphenhydramine Hydrochloride     External analgesic
    l-Menthol                                             External analgesic


  • PRINCIPAL DISPLAY PANEL

    tactcjPDP.jpgPDP


  • PRINCIPAL DISPLAY PANEL

    tactcjcart.jpgCarton


  • INGREDIENTS AND APPEARANCE
    TACT COOL  JELLY
    diphenhydramine hydrochloride, levomenthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-704
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride 2 g  in 100 g
    levomenthol (UNII: BZ1R15MTK7) (levomenthol - UNII:BZ1R15MTK7) levomenthol 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    alcohol (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    hydroxypropyl cellulose (UNII: RFW2ET671P)  
    monoethanolamine (UNII: 5KV86114PT)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49873-704-01 1 in 1 CARTON
    1 20 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/02/1997
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical Co., Ltd. 715699133 manufacture, label, pack