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
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 31, 2020

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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 not finalpart34810/02/1997
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-704) , label(49873-704) , pack(49873-704)