Label: GOOD NEIGHBOR PHARMACY ITCH RELIEF EXTRA STRENGTH- diphenhydramine, zinc acetate aerosol, spray

  • 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 September 8, 2015

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  • Drug Facts

  • Active ingredients

    • Diphenhydramine HCI 2.0%
    • Zinc Acetate 0.1%

  • Purpose

    • Topical analgesic
    • Skin protectant
  • Uses

    Temporarily relieves pain and itching associated with: • insect bites • minor

    burns • sunburn • minor cuts • scrapes • minor skin irritations • rashes due to poison

    ivy, oak and sumac • dries the oozing and weeping of poison ivy, oak and sumac

  • Warnings

    For external use only.

    Flammable:

    Do not use while smoking or near heat or flame

    Do not use

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

    When using this product

    • keep out of eyes • use only as directed.

    • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

    Ask a doctor before use

    • on chicken pox • on measles

    Stop use and ask doctor if

    • condition worsens • symptoms last more than 7 days

    • symptoms clear up and occur again in a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center.

  • Directions

    • shake well • 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 • to apply to face, spray into palm of hand and gently apply

  • Inactive ingredients

    Alcohol Denat., Glycerin, PVP, Tromethamine, Water.

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed

    by McNeil Consumer Healthcare, owner and

    distributor of the Benadryl® trademark.

    Distributed By AmerisourceBergen

    1300 Morris Drive, Chesterbrook, PA 19087

    Visit us at www.goodneighborpharmacy.com

  • Good Neighbor Pharmacy Itch Relief

    46122011421.jpg

  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY ITCH RELIEF  EXTRA STRENGTH
    diphenhydramine, zinc acetate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    Zinc Acetate (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PVP/VA COPOLYMER (UNII: D9C330MD8B)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-114-2185 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/28/2011
    Labeler - AmerisourceBergen Drug Corporation (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(46122-114) , label(46122-114)
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