Label: SELECT BRAND ITCH RELIEF- diphenhydramine hydrochloride and zinc acetate spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 3, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Diphenhydramine hydrochloride 2%Topical analgesic
    Zinc acetate 0.1%Skin protectant
  • Uses

    • temporarily 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 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 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 than directed
    • adults and children 2 years of age and older: spray on affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • Other Information

    • store at 20° C to 25° C (68° F to 77° F)
  • Inactive ingredients

    glycerin, povidone, purified water, SD alcohol 40-B, trolamine

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    SELECT BRAND DISTRIBUTORS

    Pine Bluff, AR 71603 USA, AC(870) 535-3635


  • PRINCIPAL DISPLAY PANEL

    FOR SKIN USE ONLY

    select brand

    Topical Analgesic

    Skin Protectant

    ITCH RELIEF SPRAY

    *Compare to the active ingredients in

    BENADRYL ITCH RELIEF SPRAY

    EXTRA STRENGTH

    Diphenhydramine HCl 2%

    Zinc Acetate 0.1%

    2 FL OZ (59 mL)

    PDP

    rear

  • INGREDIENTS AND APPEARANCE
    SELECT BRAND ITCH RELIEF 
    diphenhydramine hydrochloride and zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE.2 g  in 10 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE.01 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONES (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-054-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/11/2012
    Labeler - Select Brand (043562370)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(15127-054)
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