Label: TACT- diphenhydramine hydrochloride, menthol cream

  • NDC Code(s): 49873-705-01
  • Packager: Sato Pharmaceutical Inc., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • 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
    ■ minor skin irritations    ■ insect bites    ■ minor cuts    ■ scrapes
    ■ rashes due to poison ivy    ■ sunburn        ■ minor burns

  • WARNINGS

    Warnings
    For rectal 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

    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

  • INGREDIENTS AND APPEARANCE
    TACT 
    diphenhydramine hydrochloride, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-705
    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
    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)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-705-011 in 1 CARTON09/09/1997
    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 DrugM01709/09/1997
    Labeler - Sato Pharmaceutical Inc., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Inc., Ltd.715699133manufacture(49873-705) , label(49873-705) , pack(49873-705)
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