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
  • 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%
    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 not finalpart34809/09/1997
    Labeler - Sato Pharmaceutical Inc., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Inc., Ltd.715699133manufacture(49873-705) , label(49873-705) , pack(49873-705)