Label: DR. SHEFFIELD ANTI ITCH CREAM- anti itch cream cream

  • NDC Code(s): 11527-069-04
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts:

  • Active ingredients

    Diphenhydramine hydrochloride 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 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, Diazolldinyl Urea, Methylparaben, PEG 20 Sterate, Proplylene Glycol, Proplyparaben, Purified Water

  • Principal Display Panel 1.25 oz Carton

    Sheffield  Pharmaceuticals                              NDC 11527-069-04

    ANTI -ITCH cream

    Topical analgesic & Skin Protectant

    Made in the USA                       NET WT. 1.25 oz ( 35g)

    Principal Display Panel 1.25 oz Carton

  • Principal Display Panel 1.25 oz Tube

    Sheffield Pharmaceuticals                                              NDC 11527-069-04

        2% Diphenhydramine Hydrochloride and 0.1% Zinc Acetate

    ANTI-ITCH cream          

     Histamine blocker relieves itching from insect bites & skin irritations

    Topical Analgesic & Skin Protectant                 

    NET WT. 1.25oz ( 35g)

    Principal Display Panel 1.25 oz Tube

  • INGREDIENTS AND APPEARANCE
    DR. SHEFFIELD ANTI ITCH CREAM 
    anti itch cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-069
    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 ACETATE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-20 STEARATE (UNII: NBX892EA57)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-069-041 in 1 CARTON11/11/2008
    135 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/11/2008
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-069)