Label: EXTRA STRENGTH ITCH STOPPING- itch stopping cream cream

  • NDC Code(s): 52000-071-03, 52000-071-04
  • Packager: Universal Distribution Centre LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 13, 2024

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  • Uses

    • temporarily relieves pain and itching associated with:
      • 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 of poison ivy, poison oak, and poison sumac
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Diphenhydramine hydrochloride 2%Topical analgesic
    Zinc acetate 0.1%Skin protectant
  • 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 avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • symptoms persist for 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 than directed
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • Other information

    • protect from excessive heat (40°C/104°F)
  • Inactive ingredients

    cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

  • Questions?

    Call toll-free 1-800-222-1222

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Universal Distribution Centre LLC

    96 Distribution Boulevard, Edison
    NJ 08817

  • PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

    LabelEXTRA STRENGTH

    Topical Analgesic/Skin Protectant

    ITCH

    STOPPING

    CREAM

    NET WT 1.25 OZ (35.4 g)

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH  ITCH STOPPING
    itch stopping cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-071
    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
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-071-041 in 1 CARTON01/21/2021
    1NDC:52000-071-0335.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/21/2021
    Labeler - Universal Distribution Centre LLC (019180459)
    Registrant - Savvy Care and Cosmetics Pvt. Ltd. (915039748)
    Establishment
    NameAddressID/FEIBusiness Operations
    Savvy Care and Cosmetics Pvt. Ltd.915039748manufacture(52000-071)
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