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TACT (Sato Pharmaceutical Inc., Ltd.)

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CREAM 1 TUBE in 1 CARTON (49873-705-01) > 20 g in 1 TUBE Label Information

Complete TACT Information

  • ACTIVE INGREDIENT

    Active ingredients  
    Diphenhydramine hydrochloride 2.0%
    Menthol 1.0%


  • PURPOSE

    Purpose   
    Diphenhydramine Hydrochloride    External analgesic
    l-Menthol    External analgesic


  • INDICATIONS & USAGE

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


  • WARNINGS

    Warnings
    For rectal 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  butylparaben, carboxyvinyl polymer, cetyl alcohol, diethanolamine, edetate disodium, light mineral oil, PEG-40 stearate, propylene glycol, propylparaben, purified water, sorbitan monostearate, white petrolatum.


  • PRINCIPAL DISPLAY PANEL



    tactcreamcart.jpg
    carton

  • PRINCIPAL DISPLAY PANEL



    tactcreamPDP.jpg
    PDP

  • INGREDIENTS AND APPEARANCE
    TACT 
    diphenhydramine hydrochloride, menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-705
    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) (MENTHOL - UNII:L7T10EIP3A) LEVOMENTHOL 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIETHANOLAMINE (UNII: AZE05TDV2V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49873-705-01 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 09/09/1997
    Labeler - Sato Pharmaceutical Inc., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical Inc., Ltd. 715699133 manufacture, label, pack