Label: WEEKS AND LEO EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream

  • NDC Code(s): 11383-258-51, 11383-258-53
  • Packager: Weeks & Leo Co., Inc.
  • 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 March 20, 2017

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  • Active Ingredients

    Diphenhydramine hydrochloride 2%

    Zinc acetate 0.1%

  • Purpose

    Diphenhydramine hydrochloride...............Topical anagesic

    Zinc acetate..............................................Skin protectant

  • Uses

    temporarliy relieves pain and itching due to:

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

    dries the oozing and weeping due to 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 mouth

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or 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

  • Directions

    • do not use more often than directed
    • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years: ask a doctor
  • Other Information

    • store at 20º C to 25º C (68º F to 77º F)
  • Inactive Ingredients

    cetyl alcohol, diazolidinyl urea, glyceryl stearate, methylparaben, PEG-40 stearate, PEG-100 stearate, propylene glycol, propylparaben, purified water

  • Package Label - 1oz (28g)

    Extra Strength

    Est. 1892 WEEKS&LEO Professional Health

    ITCH STOPPING CREAM

    Topical Analgesic / Skin Protectant

    Net wt. 1 oz (28 g)

    pdp

  • INGREDIENTS AND APPEARANCE
    WEEKS AND LEO EXTRA STRENGTH ITCH STOPPING 
    diphenhydramine hydrochloride and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-258
    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
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11383-258-511 in 1 CARTON03/17/2014
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11383-258-531 in 1 CARTON03/17/2014
    256 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 finalpart34803/17/2014
    Labeler - Weeks & Leo Co., Inc. (005290028)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(11383-258)
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