Label: ANTI-ITCH- diphenhydramine hydrochloride and zinc acetate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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  • Drug Fact 

  • Active Ingredients

    Diphenhydramine HCL 2%

    Zinc Acetate 0.1%

  • Purpose

    Topical analgesic 

    Skin protectant 

  • Uses 

    For temporary relief from pain and itching associated with :

    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • rashes due to poison ivy, poison oak, and poison sumac

    Dries the oozing and weeping of poison

    • ivy
    • oak
    • sumac
  • Warnings For external use only

    Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine , even one taken by the mouth.

    Ask a Doctor before use

    • on chicken pox
    • on measles

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if

    • conditions worsen or does not improve within 7 days
    • symptoms persist for more than 7 days or clear up and occur agian within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions 

    • do not use more than directed
    • adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily
    • children under 2 years of age , consult a doctor

  • Other information 

    Store at controlled room temperature 20°-25°C (68° - 77°F)
    Close the cap tightly after use

  • Inactive ingredients 

    Cetyl Alcohol, Citric Acid, Diazolldinyl Urea, Glyceral Stearate, Methylparaben, Polyethylene Glycol Monsterate 1000, Sodium Citrate, Water

    (Purified)

  • Questions or comments? 1-800-910-6874

  • Principal Display Panel 

    Target Up&Up    NDC 11673-865-28

    Extra Strength Itch Relief 

    Diphenhydramine HCL 2% / Zinc Aceate 0.1%

    Anti-itch cream

    NET WT 1 OZ (28g)

    290890 Tube

    590890 Carton

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH 
    diphenhydramine hydrochloride and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-895
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 10000 (UNII: H57W405143)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-895-281 in 1 CARTON01/31/2024
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/31/2024
    Labeler - Target Corporation (006961700)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11673-895) , analysis(11673-895)
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