Label: TACT COOL JELLY- diphenhydramine hydrochloride, levomenthol gel

  • NDC Code(s): 49873-704-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • ACTIVE INGREDIENT

    Active ingredients


    Diphenhydramine Hydrochloride 2.0%   
    l-Menthol 1.0%

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    Warnings
    For external use only

    When using this product

    ■avoid contact with the eyes

    Stop use and ask a doctor if

    ■condition worsens ■symptoms persist for more than 7 days.

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

  • INACTIVE INGREDIENT

    I nactive 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

    tactcjcart.jpg Carton

  • INGREDIENTS AND APPEARANCE
    TACT COOL  JELLY
    diphenhydramine hydrochloride, levomenthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-704-011 in 1 CARTON10/02/1997
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/02/1997
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-704) , label(49873-704) , pack(49873-704)
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